Tag Archives: cannabis

FDA Approves First Cannabis-Based Drug

U.S. health regulators have approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law.

The Food and Drug Administration approved the medication from GW Pharmaceuticals on Monday, to treat two rare and serious forms of childhood epilepsy: Lennox-Gastaut syndrome and Dravet syndrome, that begin in childhood but can persist in adulthood. The strawberry-flavored syrup is a purified form of a chemical in the cannabis plant — but not the one that leads to the high. It is not yet clear why the ingredient, known as CBD, reduces seizures in some people.

The British drugmaker studied the drug in more than 500 patients with hard-to-treat seizures, overcoming numerous legal hurdles to conducting research with cannabis. FDA officials have stated that the drug reduced seizures when combined with older epilepsy drugs.

The drug is made from purified cannabidiol, or CBD, a compound found in the cannabis plant. The drug will be marketed under the brand name Epidiolex. CBD has medicinal effects, but it does not cause the mind-altering high that comes from THC, the primary psychoactive component of marijuana.

The FDA says this is the first drug approved in the U.S. that contains a purified substance derived from marijuana. The agency has previously approved drugs made from synthetic versions of THC and other marijuana constituents. “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” said FDA Commissioner Scott Gottlieb during a call with reporters about the approval.

Several states have legalized CBD oil specifically for the treatment of intractable epilepsy or seizure disorders. As media outlets have previously reported, CBD supplements are available widely online and in dispensaries in the form of oils or tinctures, and CBD oil has gained popularity with consumers as a remedy for a variety of other ailments. However, the legal status of these products is uncertain, as is their quality; they are not regulated the way pharmaceutical drugs are, so the consistency and dose can vary widely.

Having an FDA-approved, pharmaceutical-grade CBD drug will open up a new treatment option for epilepsy patients by delivering a high-quality, consistent dose of CBD, says Robert Carson a pediatric neurologist at Vanderbilt University who treats patients with epilepsy. “Our biggest concerns with the artisanal [or supplement] versions of CBD were related to the consistency,” Carson says. “We can’t guarantee the consistency.” Carson says he will likely prescribe Epidiolex going forward. “I’m always excited about the potential for a new therapy that has been well-studied and has a great potential for benefit,” he says.

Several researchers are studying the potential of CBD to treat psychiatric conditions. A clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder, and another trial will determine whether CBD could help prevent relapse in opioid abusers.

The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle. Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance. Like other drugs in this category, which include heroin and LSD, these drugs are considered to have no medical use and a high potential for abuse.

But now, with the approval of a CBD drug, the DEA will change this, according to Dr. Douglas Throckmorton, deputy director of regulatory programs at the FDA’s Center for Drug Evaluation and Research, “The DEA will need to make a different scheduling decision for CBD…because it now has an accepted medical use,” he said during a conference call with reporters. He said the reclassification is underway now.

SOURCES
https://www.theguardian.com/business/2018/jun/25/uk-epilepsy-drug-set-to-be-first-cannabis-based-medicine-on-us-market
http://time.com/5321299/fda-approves-marijuana-drug-epilepsy/
https://www.npr.org/sections/health-shots/2018/06/25/623236189/fda-green-lights-marijuana-based-pharmaceutical-drug

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Applications of Clinical Cannabis in Medicine

As clinical cannabis is rapidly becoming accepted as a treatment for an array of chronic diseases and disorders, there is a growing and pressing need for clinical education surrounding medical marijuana—and alternative treatments for pain control. The use and acceptance of medical cannabis continues to evolve, as demonstrated by the growing number of states that now permit its use and applications for specific medical indications. 

While the marijuana plant contains over 100 different chemicals—or cannabinoids—each one produces a different effect on the body. Tetrahydrocannabinol (THC) was originally identified by Raphael Mechoulam, who later also described and named anandamide: a naturally occurring endogenous cannabinoid neurotransmitter that binds to cannabinoid receptors. The human endocannabinoid system is a biological system involved in regulating a variety of physiological and cognitive processes, including appetite, pain sensation, mood, memory, fertility, etc. The CB1 receptor (THC) occurs in the central and peripheral nervous system, while the CB2 receptor is located on immune cells, and the peripheral nervous system. Cannabidiol (CBD) does not have the psychotropic effects of THC, nor does it have the memory impairment or appetite effects; the two main chemicals used in medicine are THC and CBD.

The most common use for medical marijuana in the United States is for pain control: while marijuana is not strong enough for severe pain (i.e. post-surgical pain or a broken bone), it is said to be highly effective for the chronic pain that plagues millions of Americans, particularly as they age. Part of its attraction is that it is clearly safer than opiates—almost impossible to overdose, and far less addictive—and it can take the place of NSAIDs such as Advil or Aleve, if people cannot take them due to problems with kidneys, ulcers, or GERD.

Marijuana specifically appears to ease the pain of multiple sclerosis, and nerve pain in general. This is an area in which few other options exist; moreover, those that do—such as Neurontin, Lyrica, or opiates—are highly sedating. Patients claim that marijuana allows them to resume their previous activities without feeling drugged or disengaged. Marijuana is also said to be a highly effective muscle relaxant; many users swear by its ability to lessen tremors in Parkinson’s disease. Other successful clinical applications include fibromyalgia, endometriosis, interstitial cystitis, and most other conditions where the final common pathway is chronic pain.

Further users of marijuana include management of nausea and weight loss, and treatment for glaucoma. A highly promising area of research is its use for PTSD in veterans who return from combat zones. Many veterans and respective therapists have reported drastic improvements, recommending more research and studies, and a loosening of governmental restrictions on its study. Medical marijuana is also reported to help patients suffering from pain and wasting syndrome associated with HIV, as well as irritable bowel syndrome and Crohn’s disease.

Despite lingering controversy, use of botanical cannabis for medicinal purposes represents the revival of a plant with historical significance reemerging in today’s healthcare system. Legislation governing use of medicinal cannabis continues to change quickly, necessitating that pharmacists and other clinicians stay abreast of state regulations and institutional implications. Ultimately, as the medicinal cannabis landscape continues to evolve, hospitals, acute care facilities, clinics, hospices, and long-term care centers must consider the implications, address logistical concerns, and explore the feasibility of permitting patient access to this treatment.

Senior Vice-President of A4M/MMI Joseph Maroon, MD—Clinical Professor and Vice Chairman in the Department of Neurosurgery at the University of Pittsburgh Medical Center, and expert in clinical cannabis therapies—has published a white paper on the neurological benefits of cannabinoids.

SOURCES
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5312634/
https://www.cannabis-med.org/?lng=en

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