Grow4Vets

Nonprofit Organization Provides Free Cannabis to Veterans

A nonprofit organization, dedicated to providing veterans with post-traumatic stress disorder (PTSD) and other debilitating conditions, recently gave away free cannabis to hundreds of military veterans.

Operation Grow4Vets gave away $60,000 worth of cannabis and cannabis products, as well as about $2,000 in prizes at the Denver Cannabis Giveaway on Saturday.  The event, sponsored by 3D Cannabis Club and Incredibles was organized in part to draw attention to the newest program that Operation Grow4Vets is launching.

The program, Save 1,000 Vets Project, is designed to provide 1,000 veterans with a complimentary monthly supply of safe cannabis products, in order to help veterans suffering from emotional and physical pain. Veterans will be accepted into the program on a first-come, first-served basis, based on factors including disability rating, injury, condition and household income.

The Denver Cannabis Giveaway Event took place at the Quality Inn Central Denver and provided free admission to veterans. The event was also open to members of the public who were at least 21 years old. The organization hopes to reduce the number of veterans who die because of prescription drug overdose and suicide by providing them with the resources they need to grow their own cannabis to treat their conditions.

During the event, 400 bags of cannabis-infused products were given out. This year, Colorado rejected the use of cannabis for treatment of PTSD, so the condition is not on the list of ailments for which physicians can recommend the drug for. However, it is legal in the state to give away cannabis for free.

Source: Grow4Vets

Last updated: 9/23/14; 2:40pm EST

AltMed

AltMed Collaborates with Vida Cannabis for Medical Cannabis

Sarasota-based AltMed LLC recently announced that it has signed a Strategic Alliance Agreement with Canada’s Vida Cannabis.

AltMed is a company bringing pharmaceutical precision to the development and production of medical cannabis. It is partnering with Vida Cannabis, which is working to develop uniquely high quality products to meet customer needs in the growing global marketplace for legal cannabis-products. The companies will collaborate on research, quality assurance and technical expertise. Additionally, they will pool business development knowledge to capitalize on complementary strengths in their respective markets.

“We’re deeply impressed with the level of sophistication, and operational know-how designed into the Vida Cannabis team as they work toward building the most advanced medical marijuana facility in Canada,” said AltMed’s chief executive David Wright. “We have a parallel commitment to excellence in Florida, and we’ve identified vital complementary strengths and best practices that will guarantee that both of our companies excel.”

AltMed has received preliminary Sarasota County approval to build a medical marijuana growing operation, in collaboration with an unnamed Sarasota nursery, in eastern Sarasota County. The company, headed by two former pharmaceutical executives, plans to file an application to grow and process non-euphoric medical marijuana once the Department of Health finishes its rule-making for the legislative initiative. Assuming the statewide medical marijuana amendment passes on November 4, AltMed plans to expand into an array of full-strength marijuana products.

“With a strong team coupled with complimentary values and a focus on rigorous quality assurance and research, AltMed shares both our scientific DNA and our commitment patients,” said Vida Cannabis’ CEO Greg Wilson.

Source: AltMed LLC

Last updated: 9/23/14; 12:10pm EST

THC

Marijuana for the treatment of epilepsy: A review

By: Lauren Hammond

Leticia Shea, PharmD, BCACP

Robin Wackernah, PharmD, BCPP

Matt Fete, PhD

 

Abstract

The use of Cannabis is extensive and dynamic, dependent not only on the strain of the plant, but also on the formulation and the vehicle used for administration. Several different constituents of the plant, known as phytocannabinoids, have been studied for numerous conditions, including amyotrophic lateral sclerosis, multiple sclerosis, schizophrenia, anxiety disorders and for the use in pain management.1,2,3 This article aims to provide a review of the research findings for the use of marijuana in epilepsy, including the phytocannabinoids with the most evidence shown to inhibit or diminish seizure propagation. In addition, the pathways that determine formulations for administration and a review of drug resistant epilepsy will be discussed.

Introduction

There are numerous medications and treatment options for epilepsy that have been researched in clinical trials and brought to the market in the standard, evidenced-based medicine format. Regardless, many patients with epilepsy remain resistant to treatment options and seek additional therapies for better management of their condition. In the United States it is determined that of the 3 million people that live with epilepsy, 1 million are resistant to treatment and present with uncontrolled seizures regardless of their current medication therapy.4 Many medications approved for epilepsy come with intolerable side effects that may hinder patient compliance. Marijuana research is lacking well designed clinical trials as a result of local and federal regulation.  This, however, has not stopped in-vitro and in-vivo studies. In the 1980’s two double-blinded studies with small samples sizes examined the  use the phytocannabinoid cannabidiol (CBD), in the treatment of epilepsy.5,6 Although CBD has demonstrated anticonvulsant properties, conflicting studies suggest  that other phytocannabinoids in Cannabis provide a synergistic antiepileptic benefit that cannot be achieved with CBD alone. Much of the data to support the use of marijuana in the treatment of epilepsy is based on research examining signaling pathways where different active moieties of Cannabis target, modulate and interfere with signaling responsible for seizure propagation. These initial findings provide foundational support for continued research to further determine and examine potential therapeutic benefits of marijuana in the treatment of epilepsy.

Epilepsy

Epilepsy is a broad term encompassing numerous syndromes that feature unprovoked seizure activity. The type of seizure, origination and progression can vary and the exact mechanism(s) are not fully understood. It is generally accepted that seizures occur as a result of excessive cerebral neuron discharge.7 Oscillations in excitatory activity within the brain have also been determined to be a likely factor in particular types of seizure induction.8 Phytocannabinoids such as delta (9)-tetrahydrocannabinol (THC) and CBD interact with receptors that may inhibit excitatory activity and also prevent the breakdown of endogenous cannabinoids, (endocannabinoids), which may further prevent excessive activity.

Drug Resistant Epilepsy

Drug resistant epilepsy (DRE) is defined as the inability to achieve complete seizure elimination after an adequate trial of two AEDs at therapeutic doses when used as either monotherapy or in conjunction with other anti-epileptic drugs (AEDs).9 In accordance with this definition, approximately 30-35% of patients meet the criteria for DRE.10 A population based study in Singapore reported 21.5% of patients having DRE.11

While the exact cause of DRE has not been fully elucidated, there several mechanisms proposed.  Theories include increased p-glycoprotein expression12, alterations in gamma-aminobutyric acid A (GABA) expression13, genetic polymorphisms14 and cell death secondary to mitochondrial dysfunction.15

DRE impacts a patient’s quality of life, specifically; it is associated with reduced cognition, reduced energy, altered social functioning and an overall lowered emotional well-being.16 Additionally, patients with DRE may have an increased risk of death.  High seizure frequency, multiple AEDs and years with epilepsy are potential theories that may clarify the causes of sudden unexplained death in epilepsy.17 Although not strongly demonstrated, death secondary to cardiac conduction abnormalities in DRE has also been reported.18 This reduced quality of life and increased chance of mortality emphasizes the need for medications that utilize novel mechanistic targets.   Currently, the primary mechanisms for AEDs focus on sodium or calcium channels and enhancement of GABA or inhibition of glutamate. In addition to Cannabis, glial cells19, brain derived neurotrophic factor20 interleukin-1 beta receptor caspase 1 inhibitors21 are all potential targets for the treatment of DRE.

Endocannabinoid system

The endocannabinoid system (ECS) is comprised of endogenous lipid ligands, endocannabinoids, and their receptors. It has numerous effects on the body and there remains opportunity for discovery of additional biological effects.  The main receptors of interest are G-protein-coupled cannabinoid-1 (CB1R) and cannabinoid-2 (CB2R). Our review focuses on CB1R due to its effects on neuronal transmission and how this may play a role in the prevention of seizure induction and/or propagation. CB2R is generally associated with immune function and expressed only in the periphery.22,23

CB1R is the most predominant of the two receptors and is largely expressed in the brain (substantia nigra, globus pallidus, hippocampus, cerebral cortex, putamen, caudate, cerebellum, and amygdala), with limited expression in adipose and hepatocyte tissue.22 CB1R can be activated by endogenous or exogenous cannabinoids.24 Endogenous cannabinoids, known as endocannabinoids, include anandamide (AEA) and 2-arachidonoyl glycerol (2-AG).  AEA and 2-AG are responsible for the regulation of the endocannabinoid system. They are made on demand, from increased neuronal excitability.25 Fatty acid amide hydrolase (FAAH) catabolizes AEA and monacylglycerol lipase degrades 2-AG. These are all important modulators of regulation in the ECS.22 Neuronal excitability triggers the release of endocannabinoids into the synaptic cleft from the postsynaptic neuron where they bind to presynaptic neuron CB1R resulting in inhibition of neurotransmitter release at both excitatory and inhibitory synapses.26,27  This inhibits the release of either glutamate or GABA.28 Evidence suggests that activation of CB1R on glutamatergic rather than GABAergic terminals is required for antiepileptic action of endogenous cannabinoids.29 This brief discussion of the ECS highlights the complexity of these poorly understood pathways. Research has shown that exogenous cannabinoids that interact at these receptors, including THC and CBD, provide distinctly different responses, and yet both have been shown to provide benefit in inhibiting or slowing seizure propagation. It is beyond the scope of this review to analyze all of the mechanisms responsible for Cannabis ’activity. Our goal is to highlight the complexity of the various cannabinoids found within Cannabis and summarize what research has been done with these cannabinoids in relation it their use in epilepsy.

Endocannabinoids Studied for the Use in Epilepsy

The two most common phytocannabinoids in marijuana are THC and CBD.  Both compounds, which can be derived from either strain of marijuana, Cannabis sativa or Cannabis indica, have been shown to have anticonvulsant and antiepileptic properties.22 Of the many phytocannabinoids present in Cannabis, THC and CBD are the 2 constituents with research to support their use in epilepsy. THC is the major psychoactive component of marijuana whereas CBD is the primary nonpsychoactive component. The interaction and effect when THC binds to CB1R (and CB2R) is dramatically different than that of CBD.30 THC binds to both CB1R and CB2R with relatively high affinity but lower than known synthetic CB1/CB2 receptor agonist WIN 55,212-2. WIN 55, 212-2 is a synthetic CB1/CB2 agonist which has been studied to evaluate the numerous effects of binding to cannabinoid receptors.28 THC resembles AEA affinity for CB1R but has lower efficacy than the synthetic agonists, suggesting THC to be a partial agonist.28 There is evidence to support that CBD acts as an antagonist at CB1R and CB2R. Although CBD has been determined to have low affinity for both of these receptors, it has exhibited high potency.30  The fact that THC exhibits partial agonist activity at CB1R whereas CBD exhibits antagonist activity at this receptor exemplifies the distinct differences involved with these two phytocannabinoids and their activities on receptors in the brain. Considering that THC and CBD both possess antiepileptic properties while exerting different effects on neuronal activity creates additional questions related to their clinical use in epilepsy. It may be that when THC and CBD are both used together they may provide benefit, however the ratios in relation to each other and dosing parameters are not clearly defined. Additionally, both cannabinoids have activity beyond CB1R and CB2R. It has been suggested that CBD may exhibit anti-epileptic properties as a result of multiple interactions with other receptors and ion channels.27, 31 CBD is speculated to have effects on receptors such as transient receptor potential channels, PPARϒ, GPR55, GPR18, 5HT1A and VDAC1.31, 32 When GPR55 is agonized in the brain, it mobilizes intracellular calcium elevating the presynaptic amount of calcium resulting in glutamate release.27  Interestingly, CBD is a GPR55 antagonist which would aid in glutamate release inhibition, thus decreasing the rate of the neuronal action potentials and seizure activity.27  The voltage-dependent anion channel protein (VDAC1) is a major component of the mitochondria membrane that regulates ion exchange.32 Studies propose that CBD helps to regulate the homeostasis of calcium in the mitochondria, which prevents calcium fluctuations under high excitability conditions.31, 33  It has also been suggested that CBD inhibits the reuptake and degradation of AEA by inhibiting FAAH and therefore increasing AEA’s agonistic effects on CB1R.31, 34, 35    Studies have shown that CBD works in a bi-phasic fashion demonstrating that its actions are heavily dose dependent.31  The possible synergistic or inhibitory activity with other phytocannabinoids found in marijuana such as THC are also important considerations. The inhibitory action produced by THC at CB1R offers a mechanism to diminish neuronal excitability, but at the cost of psychoactive properties and cognitive impairment. CBD’s actions provide a possible mechanism for inhibition of excitatory neurons (through different pathways involving GPR55 and resulting increased levels of AEA), but without the adverse effects mentioned above. Although there is supportive research that analyzes specific pathways for neuronal activity modulation using endocannabinoids, the full extent of each phytocannabinoid’s role is not clear.  Additional studies are needed that focus on the variety of constituents and various concentrations from different Cannabis plants, strains and formulations.

The structures of cannabinoids present in Cannabis (Figures 1 and 2) as well as the endogenous ligands of CB1R and CB2R (Figures 3 and 4) are provided. The structures of the Cannabis cannabinoids are quite similar to each other and this is also true of the endogenous cannabinoids.  Interesting, however, is that the two separate families of cannabinoids lack structural similarity to one another.  Structure is a key determinant of binding affinity, pharmacodynamics and pharmacokinetic profiles and this highlights the importance of emphasizing research that establishes ADME profiles, efficacy, potency, and clearance parameters under a variety of conditions and strategies of formulation.

THC

Figure 1. Delta (9)-tetrahydrocannabinol (THC)

CBD

Figure 2. Cannabidiol (CBD)

 

anandamide

Figure 3. Anandamide

arachidonoylglycerol

Figure 4. 2-arachidonoylglycerol

 

Currently available formulation of marijuana utilized for the treatment of epilepsy

Cannabis can be administered by inhalation, oral ingestion and topically. There is large variation in pharmacokinetic parameters depending on the route of administration. The inhalation route, either by smoking or vaporization provides the fastest onset, however lung administration burns lung tissue via direct smoke or increased temperatures with vaporization. Oral administration is associated with inconsistent absorption and onset of action. Gastric contents and first pass metabolism affect systemic absorption and dosing adjustments are recommended in the presence of food. Onset after oral administration can vary from 30 minutes to 2 hours or longer, with duration of action ranging from 5 to 8 hours.36 Little data is available on the pharmacokinetics of topical administration of cannabinoids and, to date, there are not any studies researching this formulation strategy for the use in epilepsy.36

In the state of Colorado an oil based formulation, known as Charlotte’s WebTM, is available from a non-profit organization “Realm of Caring” for the treatment of seizures in addition to other medical conditions.37 There is currently a waitlist for this formulation and patients and caregivers are required to move to Colorado in order to obtain this medical formulation of Cannabis. The formulation is stated to be highly concentrated in CBD, with less than 0.3% of THC, providing a formulation not likely to cause psychoactive activity as result of the low concentration of THC.37 Currently there are not any clinical trials evaluating the efficacy of this product, however this non-profit organization is currently working on observation trials.37

Conclusion

It is exciting to consider the possibilities that Cannabis may provide for treatment options in epilepsy. It is also evident that additional studies are needed to better understand the dynamic way in which different components of marijuana may play a role in preventing seizure activity in patients diagnosed with epilepsy. In addition, the pharmacokinetic parameters most likely to achieve therapeutic benefit without adverse effects and drug interactions require further investigation. Research is also needed to evaluate the specific metabolism of CBD and the optimization of patient centered dosing of these highly concentrated CBD formulations. Despite the need for additional research, current and ongoing clinical trials provide strong evidence to support the use of Cannabis formulations in epilepsy. This is especially true for those that are unable to achieve therapeutic success with currently available AED medications.

 

 

References

  1. Amtmann D, Weydt P, Johnson KL, Jensen MP, and Canter GT. Survey of cannabis in use in patients with amyotrophic lateral sclerosis (ALS). American Journal Hospital Palliative Care.2004;21(2): 95-104.
  2. Koppel BS, Brust JC, Bronstein J, Youssof S, Gronseth G and Gloss D. Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders: report of the Guideline Development Subcommittee of the American Academy of Neurology.Neurology.2014;82(17): 1556-63.
  3. Syed YY, McKeage K, and Scott LJ. Delta-9-tetrahydrocannabinol/cannabidiol (sativex(®)): a review of its use in patients with moderate to severe spasticity due to multiple sclerosis.Drugs.2014;74(5): 563-78.
  4. Institute of Medicine. 2012. Epilepsy across the spectrum. March 30. Accessed July 16, 2014. http://www.iom.edu/Reports/2012/Epilepsy-Across-the-Spectrum.aspx.
  5. Cunha JM, Carlini EA, and et al. Chronic administration of cannabidiol to healthy volunteers and epileptic patients.Pharmacology.1980;21(3):175-85.
  6. Ames FR, and Cridland S. Anticonvulsant effect of cannabidiol. S Afr Med J.1986;4(1):14.
  7. Elger CE, Schmidt D. Modern management of epilepsy: A practical approach. Epilepsy & Behavior.2008;12(4):501-39.
  8. Jefferys, JG. Models and mechanisms of experimental epilepsies. Epilepsia.2003;(12): 44-50.
  9. Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Hauser WA, Mathern G, Moshé SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: Consensus proposal by the ad hoc Task Force of the ILAE Commission on therapeutic strategies. Epilepsia. 2010;51(6):1069-1077.
  10. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342(5):314-319.
  11. Kong ST, Ho CS, Ho PC, Lim SH. Prevalence of drug resistant epilepsy in adults with epilepsy attending a neurology clinic of a tertiary referral hospital in Singapore. Epilepsy Res. 2014;108(7):1253-1262.
  12. Feldmann M, Asselin MC, Liu MC, Wang S, McMahon A, Anton-Rodriguez J, Walker M, Symms M, Brown G, Hinz R, Matthews J, Bauer M, Langer O, Thom M, Jones T, Vollmar C, Duncan JS, Sisodiya SM, Koepp MH. P-glycoprotein expression and function in patients with temporal lobe epilepsy: a case-control study. Lancet Neurol. 2013;12(8):777-785.
  13. Loup F, Picard F, Yonekawa Y, Wieser HG, fritschy JM. Selective changes in GABAA receptor subtypes in white matter neurons of patients with focal epilepsy. Brain.2009;132(pt 9):2449-2463.
  14. He X, Li Y, Liu Z, Yue X, Zhao P, Hu J, Wu G, Mao B, Sun D, Zhang H, Song X, Wang Y, Shao J. The association between CCL2 polymorphisms and drug-resistant epilepsy in Chinese children. Epileptic Disord. 2013;15(3):272-277.
  15. Kudin AP, Zsurka G, Elger CE, Kunz WS. Mitochondrial involvement in temporal lobe epilepsy. Exp Neurol. 2009;218(2):326-332.
  16. Alonso-Vanegas MA, Cisneros-Franco JM, Castillo-Montoya C, Martínez-Rosas AR, Gómez-Pérez ME, Rubio-Donnadieu F. Self-reported quality of life in pharmacoresistant temporal lobe epilepsy: correlation with clinical variables and memory evaluation. Epileptic Disord. 2013;15(3):263-271.
  17. Tellez-Zenteno JF, Ronquillo LH, Wiebe S. Sudden unexpected death in epilepsy: evidence-based analysis of incidence and risk factors. Epilepsy Res. 2005;65(1-2):101-115.
  18. Surges R, Adjei P, Kallis C, Erhuero J, Scott CA, Bell GS, Sander JW, Walker MC. Pathologic cardiac repolarization in pharmacoresistant epilepsy and its potential role in sudden unexpected death in epilepsy: a case-control study. Epilepsia. 2010;51(2):233-242.
  19. Heuser K, Szokol K, Taubøll E. The role of glial cells in epilepsy. Tidsskr Nor Laegeforen. 2014;134(1):37-41.
  20. Liu X, Liu J, Liu J, Liu XL, Jin LY, Fan W, Ding J, Peng LC, Wang Y, Wang X. BDNF-TrkB signaling pathway is involved in pentylenetetrazole-evoked progression of epileptiform activity in hippocampal neurons in anesthetized rats. Neurosci Bull. 2013;29(5):565-575.
  21. Vezzani A, Balosso S, Maroso M, Zardoni D, Noé F, Ravizza T. ICE/caspase 1 inhibitors and IL-beta receptor antagonists as potential therapeutics in epilepsy. Curr Opin Investig Drugs. 2010;11(1):43-50.
  22. McPartland JM, Guy GW, Di Marzo V. Care and feeding of the endocannabinoid system: a systematic review of potential clinical interventions that upregulate the endocannabinoid system.” PLOS ONE.2014;9(3): e89566.
  23. Fezza F,Marrone MC, Avvisati R, Di Tommaso M, Lanuti M, Rapino C, Mercuri NB,  Maccarrone M, and Marinelli S. Distinct modulation of the endocannabinoid system upon kainic acid-induced in vivo seizures and in vitro epileptiform bursting. Molecular and Cellular Neuroscience.2014;62C:1-9.
  24. Pertwee RG. Targeting the endocannabinoid system with cannabinoid receptor agonists. Philos Trans R Soc Lond B Biol Sci.2012;367(1607):3353-63.
  25. Dlugos A, Childs E, Stuhr KL, Hillard CJ, and de Wit H. Acute stress increases circulating anandamide and other N-Acylethanolamines in healthy humans. Neuropsychopharmacology.2012;37(11): 2416-2427.
  26. Skaper SD, Di Marzo V. Endocannabinoids in nervous system health and disease: the big picture in a nutshell. Philos Trans R Soc Lond B Biol Sci.2012;367(1607):3193-200.
  27. Sylantyev S, Jensen TP,  Ross RA, and Rusakov DA. Cannabinoid- and lysophosphatidylinositol-sensitive receptor GPR55 boosts neurotransmitter release at central synapses. Proc Natl Acad Sci U S A.2013;110(13): 5193-5198.
  28. Pertwee RG. The diverse CB1 and CB2 receptor pharmacology of three plant cannabinoids: delta9-tetrahydrocannabinol, cannabidiol and delta9-tetrahydrocannabivarin. British Journal of Pharmacology.2008;153(2): 199-215.
  29. Hofmann ME, Frazier CJ. Marijuana, endocannabinoids, and epilepsy; potential and challenges for improved therapeutic intervention. Experimental Neurology.2013;244: 43-50.
  30. Thomas A., Baillie GL, Phillips AM, Razdan RK, Ross RA, and RG Pertwee. Cannabidiol displays unexpectedly high potency as an antagonist of CB1 and CB2 receptor agonists in vitro.Br J Pharmacol. 2007;150(5):613-23.
  31. Cilio MR, Thiele EA, Devinsky O. The case for assessing cannabidiol in epilepsy. Epilepsia. 2014;55(6):787-90.
  32. Rimmerman, N., D. Ben-Hail, Z. Porat, A. Juknat, E. Kozela, MP. Daniels, PS. Connelly, E. Leishman, HB. Bradshaw, V. Shoshan-Barmatz, and Z. Vogel. 2013. Direct modulation of the outer mitochondria membrane channel, voltage-dependent anion channel 1 (VDAC1) by cannabidiol: A novel mechanism for cannabinoid-induced cell death.” Cell Death Dis. 20135;4:e949.
  33. Ryan D, Drysdale AJ, Lafourcade C, Pertwee RG, Platt B. Cannabidiol targets mitochondria to regulate intracellular Ca2+ levels. J Neurosci. 2009;18;29(7):2053-63.
  34. Ryan D, Drysdale AJ, Pertwee RG, Platt B. Interactions of cannabidiol with endocannabinoid signaling in hippocampal tissue. Eur J Neurosci. 2007;25(7):2093-102.
  35.  Fernandez-Ruiz J, Sagredo O, Pazos MR, Garcia C, Pertwee R, Mechoulam R, Martinez-Orgado J. Cannabidiol for neurodegenerative disorders: important new clinical applications for this phytocannabinoid? Br J Clin Pharmacol. 2013;75(2):323-33.
  36. Aggarwal SK. Cannabinergic pain medicine: a concise clinical primer and survey of randomized-controlled trial results. Clin J Pain. 2013;29(2):162-71.
  37. Realm of Caring. 2014. FAQ General: Realm of Caring. Accessed September 13, 2014. http://theroc.us/index.php?option=com_content&view=article&id=77&Itemid=427.

 

 

 

 

 

 

 

 

medical marijuana

Italian Army to Grow Medical Cannabis in Secure Lab

The Italian army has decided to start growing medical cannabis at a secure lab outside Florence.

Today, the ministers of defense and health signed a deal for a joint project to produce cannabis derivative drugs for pain relief. The goal is to produce pain killers locally at a cheaper price than those imported. The cannabis would be distributed through pharmacies to reduce costs and make it more easily available to patients.

The agreement was signed in Rome in front of the press between the Minister of Health Beatrice Lorenzin and the Minister of Defense Roberta Pinotti.

The cannabis will be cultivated and processed at a military chemical and pharmaceutical plant, which currently makes orphan drugs no longer made by large pharmaceutical companies that are needed to treat rare diseases, according to Pinotti. The aim is to produce medicine for extremely serious conditions, such as multiple sclerosis and pain relief.

The project should produce around 80 to 100 kilos (180 to 440 pounds) of active principle – the extract from cannabis plants used in medicine- each year. The ingredients will be delivered to local pharmacies and hospitals which will prepare the specific drugs.

Currently, there is one cannabis-based drug available in Italy for the treatment of multiple sclerosis (MS). All others have to be imported from abroad under long and expensive procedures. According to Lorenzin, the price of the drugs produced locally will be much less than half of the cost currently supported by social security.

The Administers describe the measure as a pilot program, which should result in the cannabis-based medicines being delivered to pharmacies by the end of 2015.

Last updated: 9/18/14; 3:30pm EST

cannabis science

Cannabis Science Partners with Unistraw for Unique Cannabis Extracts and Pure Cannabinoid-Based Products

Cannabis Science, Inc. is partnering with Unistraw Holdings to produce proprietary formulations delivering cannabis and hemp extracts and pure cannabinoid-based products.

The companies recently announced the signing of a globally-exclusive, collaborative agreement, which provides for the immediate initiation of proprietary formulation to deliver a wide array of unique cannabis and hemp extracts and pure cannabinoid-based products using the patented Unistraw Delivery Systems (UDS). With the successful outcome of effective formulations, Cannabis Science and Unistraw have agreed to form a joint venture to further refine, develop and bring a variety of proprietary cannabis, hemp and cannabinoid-based nutraceutical and pharmaceutical products to market.

The companies will share in the development of new intellectual property and novel advancements of the venture.

“We believe Cannabis Science’s collaboration with Unistraw may be one of the most significant milestones in cannabis medical industry,” said Dorothy H. Bray, PhD, Director, President and CEO of Cannabis Science, Inc. “We expect our ultimate products to be highly competitive in every sector of the world’s current and future regulated cannabis industry not only because of the unique, high-quality formulations and delivery methods but also because of the expected precision of dosing of active ingredients for medical uses,” added Mr. Suchet Rastogi, CEO of Unistraw Holdings Pte. Ltd.

The Joint Venture Viability and Operating Agreement, sets forth the developmental path and the follow-on joint venture creation mechanism, which Cannabis Science will own 50.1 percent of and Unistraw will own 49.9 percent.

The UDS is a patented system broadly covering straw-like devices containing stabilized spherical pallets of formulated product that dissolve gradually and predictability in liquids, thereby continually releasing precise doses of active ingredients throughout the drinking process. It is expected that Cannabis Science will continue to this joint venture its IP based products under development in the area of neurological conditions including sleep disorders, thereby ensuring precise delivery.

Source: Cannabis Science, Inc.

Last updated: 9/18/14; 1:50pm EST

 

cannabis compounds

United Patients Group Highlights the Top 5 Cannabinoids with Medical Properties

The United Patients Group, a team dedicated to providing the most discrete, professional and safe resource for medical cannabis, explains the top five cannabinoids that help medical cannabis patients heal.

The cannabis plant has 480 chemical compounds, and many of these have medicinal properties. The United Patients Group explains how one of these, cannabinoids, interact with the body’s endocannabinoid system to help maintain stability, and provides an overview of the five most important cannabinoids and what they do.

“As researchers delve into the question of how medical cannabis help patients, they are continually discovering that many compounds in the plant have significant medicinal value, and that the interaction of these chemicals make them even more effective,” said John Malanca, founder of United Patients Group. “We want to share these findings with our readers.”

The human body has a built-in system, known as the endocannabinoid system that works to maintain stability in the body. Receptors in the immune and nervous systems, CB1 and CB2, bind with chemicals produced inside the body; however they also bind with cannabinoids found in the cannabis plant. When the body is out of balance due to any number of ailments, cannabis encourages healing by stimulating these receptors.

Δ9-Tetrahydrocannabinol (THC) is the first cannabinoid discussed. In addition to its psychoactive effects, THC increases appetite and eases pain. THC is used to treat cancer, side effects from HIV/AIDS treatment, chronic pain, multiple sclerosis (MS), glaucoma, fibromyalgia, Huntington’s disease, ALS, Tourette’s syndrome, pruritus, and sleep apnea. Cannabidiol (CBD) is a chemical that has been the topic of several news headlines lately, due to its ability to help children with severe epileptic disorders. According to the group, CBD helps with epilepsy, seizure disorders, nerve pain, cancer, MS, chronic pain, anxiety, diabetes, arthritis, dystonia, Crohn’s disease, and inflammation.

If cannabis is exposed to too much air or heat, the oxidation of THC will create cannabinol (CBN) over time. Used alone, CBD only has mild psychoactive effects, but when combined with THC it produces what the group calls the “couch lock” feeling. Although this feeling is not helpful during the day, it is beneficial for people with sleep disorders. Additionally, CBN is an antiemetic and anticonvulsant. Cannabigerol (CBG) is a building block for both THC and CBD. It has antibacterial and anti-tumor properties, and helps reduce intraocular pressure in glaucoma patients, reduce nausea, temper anxiety, and relieve inflammatory bowel disease.

The fifth important cannabinoid discussed by the United Patients Group is cannabichromene (CBC). CBC is the second most-common cannabinoid in many strains of cannabis, following THC. It has no psychoactive effects, but eases pain, arrests tumor growth, regenerates bone and brain cells and puts the user in a better mood. CBC also has antibacterial and antifungal properties.

“These cannabinoids all have important medicinal value on their own, but research shows that together they have an ‘entourage effect’ that amplifies their healing power. Finding the right proportion of cannabinoids in your medicine can help you target your particular ailments effectively,” said Malanca.

Source: United Patients Group

Last updated: 9/18/14; 11:45am EST

Aphios

Aphios Awarded Grant for Developing cGMP Process for CBD Using Green Drug Technology

Today, Aphios Corporation announced that the National Institute on Drug Abuse (NIDA), NIH awarded Phase I of a Fast Track SBIR grant to develop a process for manufacturing cGMP cannabidiol (CBD) using its green drug manufacturing technology.

The main goal of the research program is to develop a process for manufacturing pharmaceutical grade CBD following current Good Manufacturing Practice (cGMP) of the US Food and Drug Administration (FDA) for use in clinical trials for multiple sclerosis (MS), childhood epilepsy and other central nervous system (CNS) indications by the NIH and other researchers. Having readily available pharmaceutical-grade CBD, manufactured following cGMP, will facilitate clinical evaluation by investigators at the NIH and other researchers for epilepsy, MS and other CNS diseases.

Additionally, the process developed will be used for the manufacturing of Δ9-THC, already in use for cancer pain and nausea and AIDS-related cachexia, and other cannabinoids currently in development, such as cannabigerol (CBG).

“We believe that CBD can be cost-effectively manufactured from high CBD content Cannabis sativa (hemp) utilizing supercritical fluid technology, and that such a process could also produce other bioactive cannabinoid mixtures for future research and therapeutic use,” said Dr. Trevor P. Castor, CEO and Principal Investigator on this grant. “We propose to manufacture pharmaceutical-grade CBD following cGMP guidelines by utilizing supercritical fluids and near-critical fluids with or without polar co-solvents such as alcohols (SuperFluids™). These fluids are gases such as carbon dioxide which when compressed, exhibit enhanced thermodynamic properties that can be ‘fine-tuned’ for rapid and selective extraction of bioactive molecules. Products of our critical fluid extraction and purification (CXP) manufacturing technology are free of toxic organic solvents, environmentally friendly and truly ‘green.’”

Source: Aphios Corporation

Last updated: 9/16/14; 3:15pm EST

 

Marys Medicinals CPJ

Mary’s Medicinals Launches New Line of Cannabinoid Supplements

Today, Mary’s Medicinals, an exclusive producer and distributor of transdermal cannabis patches, gels and compounds, announced a line of Terpene Enriched cannabinoid supplements including the first capsule to feature isolated CBN.

The company said that it is expanding its line of nutraceutical products to meet the growing demand for reliably dosed, smokeless, non-psychoactive marijuana consumption options. Mary’s expanded products will include capsules that complement its transdermal patches, compounds and gels.

Over the next coming weeks, the company will launch three formulations of capsules, which will be available in Washington and Colorado. These capsules include CBN, CBN/THC-A blend, and CBD. Cannabinol (CBN) is an effective anti-epileptic, anti-spasmodic and reliever of intra-ocular pressure. Evidence from recent studies suggest that CBN can be administered as an antidepressant, to prevent convulsions and to sedate patients experiencing pain. It is ideal for individuals suffering from Glaucoma, inflammation and insomnia.

Tetrahydrocannabinolic Acid (THC-A) is the non-activated, non-psychotropic acid form of THC. It is a known anti-inflammatory and cell growth inhibitor, which provides many of the same benefits of THC but without psychotropic side effects.

Cannabidiol (CBD) has shown to be effective in treating inflammation, diabetes, cancer, and mood disorders, such as PTSD and ADD, as well as neurodegenerative diseases, such as Alzheimer’s disease. CBD has an anti-epileptic, anti-anxiety, anti-psychotic, anti-nausea, anti-rheumatoid arthritis and sedative properties.

“Mary’s is dedicated to crafting the highest quality medicine utilizing the powerful healing properties of cannabinoids to optimize patient care. In the creation of each of Mary’s products, thoughtful consideration is given to replenishing vital terpenes that are typically lost in the production of most cannabis products. We strive to ensure our products are not only accurately dosed and cleanly delivered, but comprised of everything nature intended,” said Nicole Smith, CEO, Mary’s Medicinals.

All of Mary’s capsules are 100 percent plant-based, vegan, GMO-free, gluten-free and contain to additives or organic volatile impurities. Every batch of products is laboratory tested for quality, accuracy and consistency.

Source: Mary’s Medicinals

Last updated: 9/16/14; 1:40pm EST

 

 

Baird

NSW to Conduct Clinical Trial for Medical Cannabis

The New South Wales (NSW) government in Australia has decided to sponsor a clinical trial of cannabis for people suffering from terminal illnesses.

Terminally ill patients will soon be able to use cannabis without fear of being prosecuted, as the government moves closer to legalizing the drug for medical purposes.

The government’s decision is likely to formalize a protocol which allows police not to take action to the use of cannabis by patients in their last days of life. NSW Premier Mike Baird, who made the announcement today, has asked a working group to report on this matter by the end of 2014, and come up with a plan to ensure that these patients can obtain the drug, or products derived from it.

Baird said that the move formalized what police were already doing.

According to Baird, the clinical trial would explore the role of cannabis in providing relief for patients suffering from various debilitating or terminal illnesses, to enhance the understanding of its medical use.

The issue gained momentum earlier this year when Nationals MP Kevin Anderson said that he would introduce a private member’s bill to legalize cannabis for medical purposes. Baird told Parliament he was touched by the story of terminally ill Daniel Haslam, a 24-year-old diagnosed with bowel cancer.

Haslam’s mother Lucy has been leading a campaign to legalize medical cannabis for her son, who found that cannabis offered some relief to the severe side effects associated with chemotherapy.

Under Mr. Anderson’s proposal, those living with a terminal illness would be issued with a special license and allowed to have 15 grams or less of dry cannabis.

NSW Opposition leader John Robertson said if the government did not support a medical cannabis bill, Labor would take its own policy to the March state election.

Several international regions have legalized cannabis for medical purposes, including 23 states in the US, the Netherlands, Canada and Israel.

 

 

 

 

AHPA

AHPA Publishes Recommendations of Cannabis Oversight for Regulators

The American Herbal Products Association (AHPA) recently announced that it has published recommendations for regulators, providing an oversight framework that promotes best practices for cannabis production and distribution from seed to consumption.

The Association’s recommendations address issues related to the safe use and responsible commerce of products derived from cannabis species that are being legally marketed.  The recommendations, issued by AHPA’s Cannabis Committee, have been considered by many states in their development of state medical cannabis program regulations including Illinois, Massachusetts, Nevada and Oregon. The recommendations are also the foundational documents for the Americans for Safe Access (ASA) Patient Focused Certification Program, a third-party certification program that helps ensure the quality and consistency of medical cannabis products and services.

Thirty-five states have laws specific to medical cannabis or cannabidiol (CBD), a marijuana derivative, according to NORML, an organization working to legalize marijuana for adults. Colorado and Washington have also legalized the drug for recreational use. However, at the federal level marijuana is still considered illegal under the Controlled Substances Act. In 2010, AHPA chartered a Cannabis Committee to address issues created by the legalization of cannabis in several states.

“AHPA encourages regulatory authorities in states and local municipalities where use of cannabis is allowed under local law to adopt these recommendations in order to promote the responsible commerce of this important botanical,” said AHPA cannabis committee chair Tim Smale, founder and executive director of the nonprofit Remedy Compassion Center in Maine. “These best practice recommendations provide a framework for the oversight of cannabis production and distribution practices from seed to consumption.”

The Association developed recommendations to address four operational stages of cannabis production and distribution including cultivation and processing operations, manufacturing and related operations, laboratory operations and dispensing operations.

Source: American Herbal Products Association

Last updated: 9/11/14; 3:35pm EST