Sativex

Wales Approves Sativex for Treatment of Spasticity Associated with Multiple Sclerosis

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Wales has become the first country in the UK to approve the use of a cannabis-based medicine to treat symptoms of patients with multiple sclerosis (MS).

Wales is the first UK nation to approve NHS funding for Sativex (nabiximols), an oral spray derived from cannabis.  Welsh health minister Professor Mark Drakeford approved NHS funding of the drug, following a recommendation from the independent All Wales Medicine Strategy Group (AWMSG).

AWMSG’s decision comes despite a recommendation made earlier this year in a draft guidance by the National Institute for Health and Care Excellence (NICE) that the drug should not be made available in England and Wales, determining that the drug was not cost effective. With AWMSG’s approval, clinicians in Wales can now prescribe the medicine to treat muscle spasms in MS patients, should other forms of treatment not provide satisfactory results. Patients must show an improvement in symptoms after a trial period of receiving the drug.

AWMSG’s decision is in contrast to the guidance NICE has published in its draft Clinical Guideline on the management of multiple sclerosis in primary and secondary care, which concluded that Sativex was not recommended for use by the NHS. The MS Trust has been in communication with NICE and have requested a delay in the publication of the final guidance to enable further engagement with the MS community and ensure that the final guideline offers the best available care for MS patients.

Sativex was developed by GW Pharmaceuticals and is being marketed in the UK by Bayer Schering Pharma. The drug is a combination of two extracts from the cannabis sativa plant: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The drug is available as a spray to be administered onto the oral mucosa.

“We are extremely pleased that people with MS in Wales will finally have better access to Sativex. As a charity we have campaigned over a long period for Sativex to be widely available because of the significant impact that MS spasticity can have on daily activities. We just hope that this recommendation will now lead to Sativex being more easily accessible in the rest of the UK,” said Amy Bowen, Director of Service Development, MS Trust.

In a clinical trial evaluating Sativex in over 500 MS patients, 48 percent had a 20 percent or more improvement in their spasticity. Among those who responded, about 75 percent had an improvement of greater than 30 percent in their spasticity score within four weeks when compared to those taking placebo.

MS is a neurological condition which affects around 100,000 people in the UK, according to the Multiple Sclerosis Society. Most people with the condition are diagnosed between the ages of 20 and 40, but it can affect younger and older people too. MS is significantly more common among women. Roughly three times as many women have MS as men. MS symptoms include vision problems, balance problems and dizziness, fatigue, bladder problems, and stiffness and/or spasms. Additionally, the condition can affect memory and thinking and have an impact on emotions.

Sources: MS Trust; All Wales Medicines Strategy Group

Last updated: 8/21/14; 2:45pm EST

Sativex

Cannabis-Based Medicines Approved in Ireland for Patients with Multiple Sclerosis

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The Department of Health has confirmed that authorized cannabis-based medicinal products have been approved for use in patients with multiple sclerosis (MS) in Ireland.

On Friday, Ireland’s Junior Health Minister Alex White signed regulations to enable authorized cannabis-based medicinal products to be legally prescribed by medical practitioners and used by patients. The measure means that sufferers of MS will soon be able to legally use Sativex, an oral spray containing cannabis extracts, which has proven to help some patients with spasticity related to MS.

The Health Products Regulatory Authority, formerly the Irish Medicines Board, recommended approval of the product in 2012; however since the law banned all types of cannabis under the Misuse of Drugs Act its use remained against the law. The granting approval enabling this product to be used in Ireland was dependent on changes to the Misuse of Drugs Regulations.

Sativex is currently used by MS patients in eleven other countries in the European Union (EU) including the UK, Spain, Italy and Germany. The drug has shown to ease symptoms and significantly improve the quality of life of people suffering from illnesses such as MS.

“I’m glad that many of the matters that had inhibited the progress of this issue have now been resolved. Hopefully, with the legal impediments now removed, a cannabis-based medicinal product will soon be available to ease the symptoms of spasticity for people with MS where other conservative treatments have failed,” said Deputy White, who has since signing been made Minister for Communications, Energy and Natural Resources.

Last updated: 7/15/14; 2:15pm EST

 

Cannabis and MS

Ireland May Allow Medical Cannabis for Patients with Multiple Sclerosis

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The CEO of Ireleand’s Health Products Regulatory Authority (HPRA) recently confirmed that the Department of Health is drafting legislation to allow patients with multiple sclerosis (MS) access to medical cannabis.

HPRA’s CEO Pat O’Mahony spoke on RTE’s Today with Sean O’Rourke show saying that cannabis was prescribed in many European countries and was very helpful for the muscle spasms associated with MS. O’Mahoney described the move as a “very important step forward” and said that this has been proposed for roughly four years. Regulations, which are expected to be introduced in the coming weeks, allow for cannabis-based medical products to be prescribed by physicians and distributed through pharmacies.

“This will be a prescription product, so MS sufferers will have the prescription written by their [physician] and then dispensed by the pharmacist,” Mr. O’Mahony said on the radio program.

O’Mahony explained that the current laws were used in a High Court appeal around the selling of certain items in Head Shops and that the government is working out changes to the drugs laws. He said that the High Court appeal was recently resolved and policy makers in the Department of Health are about to issue a revision to the legislation that will make cannabis available in the marketplace.

“Ongoing research into the benefits of medicinal cannabis and cannabis-based medication extract for the symptoms of MS has shown the efficacy of such treatments to alleviate spasticity, sleep disorders, pain and other symptoms associated with MS,” said MS Ireland’s Chief Executive Ava battles. “MS Ireland believes people with MS should have access to all and any appropriate and licensed treatments that would improve or assist in the management of their condition.”

Last updated: 7/10/14; 12:05pm EST

 

FDA

FDA Reviewing the Classification of Marijuana as a Schedule 1 Substance

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The US Food and Drug Administration (FDA) is currently conducting research to determine if marijuana should continue to be classified as a Schedule 1 drug in the US, or if its classification should be downgraded, a step toward decriminalizing the drug at the federal level.

The agency is conducting the research at the Drug Enforcement Administration’s (DEA) request, according to a statement from Douglas Throckmorton, Deputy Director for Regulatory Programs at the FDA, at a congressional hearing. The study could lead to the removal of marijuana from the Schedule 1 category of the Controlled Substances Act.

Marijuana’s potential use for a range of medical conditions has gained significant interest over the last few decades. Recently, several states have passed laws that remove state restrictions on health care professionals using marijuana as a medical treatment for a variety of conditions.

Currently, 23 states and the District of Columbia have legalized use of marijuana for medical purposes. Additionally, several other states are considering similar legislation, regarding the use of medical marijuana. Although nearly half of the US states have legalized some form of marijuana, the drug is still classified as a Schedule 1 substance. Drugs that are classified as Schedule 1 drugs have the most restrictions and are considered substances with no medical benefit that are highly addictive.

The reclassification of marijuana could have a significant impact on the cannabis industry, and could help reconcile some of the differences between federal laws and less restrictive state laws.

The agency will make a recommendation after conducting an eight-factor analysis that evaluates marijuana’s abuse potential, its pharmacological effect and risk to public health, among other factors, according to Throckmorton. The FDA must first consult with the National Institute on Drug Abuse and send its recommendation through the Department of Health and Human Services before going to the DEA.

Last updated: 6/24/14; 2:40pm EST

 

Medical Marijuana in NY

New York Approves Medical Marijuana Bill

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New York lawmakers ended their six-month session last week, striking a deal with Gov. Andrew M. Cuomo that would authorize qualifying patients to obtain medical marijuana.

Gov. Cuomo and Legislative leaders announced an agreement on a bill that will establish a medical marijuana program for New York State. The vote will make New York the 23rd state, along with the District of Columbia, to legalize marijuana for medicinal purposes. The legislation includes provisions to make sure that medical marijuana is reserved only for patients with serious conditions, and prohibits the drug to be smoked.

“This legislation strikes the right balance,” said Governor Cuomo. “Medical marijuana has the capacity to do a lot of good for a lot of people who are in pain and suffering, and are in desperate need of a treatment that will provide some relief. At the same time, medical marijuana is a difficult issue because there are risks to public health and safety that have to be averted. I believe this bill is the right balance, and I commend the members of the Legislature who worked so hard on this measure.”

The legislation establishes a certification and registry process for doctors to administer medical marijuana. The legislation approves the use of medical marijuana for ten conditions including cancer, HIV/AIDS, ALS (Lou Gehrig’s Disease), Parkinson’s Disease, multiple sclerosis, damage to the nervous tissue of the spinal cord with objective neurological indication on intractable spasticity, epilepsy, inflammatory bowel disease, neuropathies, Huntington’s Disease, or ad added by the commissioner by the Department of Health (DOH).

“Today marks an historic victory for thousands of New Yorkers who will no longer have to suffer needlessly during their courageous medical battles. Under this bill, New Yorkers will now have the same access to life-changing treatment options that others around the country have had. Today we celebrate this victory with the countless patients, families, advocates, health care professionals and physicians who have all fought passionately for the same and reliable use of medical marijuana as part of a comprehensive course of treatment for disease and illness,” said Senator Diane Savino, who co-sponsored the bill.

The medical marijuana program is expected to start in the next 18 months. Gov. Cuomo is expected to sign the medical marijuana bill into law this week.

Last updated: 6/24/14; 11:00am EST

 

Marijuana Research

30 Members of Congress Ask HHS to Facilitate Medical Marijuana Research

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On Tuesday, thirty members of Congress sent a letter to the Secretary of the Department of Health and Human Services (HHS), requesting that the government to ease the process of obtaining marijuana for research purposes.

The letter, led by Reps. Earl Blumenauer, H. Morgan Griffith, Dana Rohrabacher and Jan Schakowsky, was sent to HHS Secretary Sylvia Matthews Burwell, in support for increasing scientific research on the therapeutic risks and benefits of marijuana.

The letter comes shortly after the House voted to block the Drug Enforcement Administration (DEA) from interfering with medical marijuana operations that are legal under state laws. Additionally, just last week, physicians claimed that the agency had threatened to revoke their license because of their involvement in medical marijuana operations.

The letter asks the Burwell “take measures to ensure that any non-National Institutes of Health (NIH) funded researcher who has acquired necessary Food and Drug Administration (FDA), Institutional Review Board (IRB), Drug Enforcement Administration (DEA) and appropriate state and local authority approval be able to access marijuana for research at-cost without further review.”

Currently, 22 states and the District of Columbia have passed laws that legalize the use of medical marijuana. Even though almost half of the states in the US have legalized some form of medical marijuana, the federal government still labels marijuana as a Schedule I substance. Unlike any other drug classified as a Schedule I substance, marijuana requires an additional Public Health Service review for non NIH-funded protocols. Under the review process, the University of Mississippi contracted by the National Institute on Drug Abuse (NIDA) is the only source of marijuana that can be legally used for research.

“In light of the fact that substances like opioids and barbiturates have been researched and developed for human use, it would seem that we should investigate the legitimate medical uses of marijuana. We request that you review and revise the HHS Guidance to eliminate what we believe to be an unnecessary additional review process. NIDA should provide marijuana at-cost to all non-NIH funded marijuana research protocols that have successfully obtained necessary FDA, DEA, IRB and appropriate state and local authority approval,” the members of Congress write.

There is significant anecdotal evidence from patients, caregivers and physicians of marijuana’s therapeutic benefit for treatment of individuals suffering from cancer, epilepsy, glaucoma, anxiety, chronic pain and more. According to the letter, over one million Americans currently use marijuana for medicinal purposes at the recommendation of their doctor. Unfortunately, scientific research demonstrating these benefits has often been hampered by federal barriers. In the letter, the members of Congress say that more scientific information on the therapeutic risks and benefits of marijuana is needed.

 

Cuomo

Governor Cuomo Pushes for a Stricter Medical Marijuana Bill

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Today, New York Governor Andrew Cuomo said that he would not sign a bill that would legalize medical marijuana in the state unless several changes were implemented.

Cuomo has delivered a list of demands that he requires prior to supporting the medical marijuana bill, known as the Compassionate Care Act. Negotiations between Cuomo’s office, the Assembly and the Senate began only late last Thursday and are due before midnight so the Legislature can vote on the bill before the session concludes June 19.

Cuomo’s full list of changes was obtained by advocates, many of which are already addressed in the current legislation. The delay in announcing these demands have caused many to believe that he is not serious in passing it. Sponsors of the bill have already agreed to several of the changes to appease Cuomo; however additional changes require restricting eligible diseases, banning smoking, and lowering doses.

Cuomo’s demands include eliminating serious conditions, including Alzheimer’s, ALS, and muscular dystrophy, and preventing cancer patients and individuals living with HIV from using medical marijuana to treat the side effects of their medications and chemotherapy, like nausea, wasting, and treatment-related pain. Additionally, Cuomo wants to eliminate post traumatic stress disorder (PTSD) and traumatic brain injury, conditions for which medical marijuana has shown to be beneficial. Cuomo requests the removal of a health advisory panel that would decide which disease the drug could be used for and instead giving that authority to New York’s health commissioner.

The changes also include reducing the amount a patient could receive per month from 2.5 ounces every 30 days to 2 ounces.

Cuomo’s changes would also require physicians recommending medical marijuana to be pre-approved by the Department of Health (DOH) and give DOH the ability to over-ride the recommendations of physicians participating in the program in regards to the dosing and administration route. He also recommended reducing the number of manufacturers in the state to five and the number of dispensaries to twenty for the entire state.

“Governor Cuomo is proposing unprecedented interference in the doctor-patient relationship and erecting so many barriers to participation in the medical marijuana program that few, if any, physicians will take part. There is no other medication for which DOH is allowed to come in and abridge the authority and particulars of a physician’s recommendation to his or her patient. I am hoping that such overly restrictive and intrusive language does not appear in the final negotiated bill,” said Sunil Aggarwal, MD, PhD, Co-chair of NY Physicians for Compassionate Care, a group representing more than 600 New York physicians.

multiple sclerosis

Certain Forms of Marijuana May Ease Symptoms of Multiple Sclerosis

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 Oral forms of medical marijuana, such as pills or sprays, may ease patients’ symptoms of multiple sclerosis, according to a new guideline from the American Academy of Neurology (AAN).

A new guideline from the AAN suggests that there is little evidence that most complementary or alternative medicine therapies (CAM) treat multiple sclerosis (MS) symptoms, but that the CAM therapies oral cannabis, or medical marijuana pills and oral medical marijuana spray may ease patients’ reported symptoms of spasticity, spasticity-related pain and frequent urination in MS. However, according to the guideline, there is a lack of existing evidence to determine whether smoking marijuana eases MS symptoms.

The new guideline was published Monday in AAN’s journal Neurology. The guideline is among the first from a national medical organization to suggest that physicians might offer cannabis treatment to patients.

The guideline looked at CAM therapies, which are nonconventional therapies used in addition to or instead of doctor-recommended therapies. CAM use is prevalent in 33 – 80 percent of MS patients, particularly among female patients, patients who have higher education levels, and patients who report poorer health. The guideline looked at whether CAM reduced MS symptoms, had adverse effects, and interfered with other MS therapies.

Researchers found strong evidence supporting the benefit of the pill form of medical marijuana in decreasing spasticity and pain from spasticity among MS patients, as well as moderate evidence that synthetic medical marijuana in pill form decreases spasticity and pain from spasticity. Moderate evidence was found that tremor symptoms were not relieved by taking either medical marijuana or synthetic medical marijuana in pill form. For the spray form of medical marijuana, researchers found moderate evidence that it improved spasticity and pain caused by spasticity, as well as frequent urination in MS patients. Moderate evidence showed that the spray form of medical marijuana does not help with incontinence, and there is weak evidence that it relieves tremors.

According to researchers, long-term safety of medical marijuana use in the form of pill or oral spray is not known. Side effects of medical marijuana in the form of pill or spray include seizures, dizziness, thinking and memory problems as well as psychological problems such as depression.

MS is an autoimmune disease affecting the central nervous system (CNS). MS patients’ immune system attacks the CNS, damaging the myelin. Myelin damage results in the formation of dense, scare-like tissue, known as lesions, which distort and interrupt signals coming to and from the brain and spinal cord. There are an estimated 40,000 Americans diagnosed with MS, and more than 2.3 million MS patients worldwide.

Sources: American Academy of Neurology; National Multiple Sclerosis Society

Last updated: 3/25/14; 11:05am EST