FDA Approves Marijuana-Based Drug To Treat Severe Epilepsy

  • FDA Approves Marijuana-Based Drug To Treat Severe Epilepsy

FDA Approves Marijuana-Based Drug To Treat Severe Epilepsy

Aside from Epidiolex, GW Pharma also sells Sativex-which includes components of marijuana-in 30 countries as a treatment for multiple sclerosis-related spasticity.

But before the medicine can hit the market in those areas, the Drug Enforcement Administration must reclassify marijuana, now a Schedule I drug, along with heroin and Ecstasy, that is described as a substance with "no now accepted medical use and a high potential for abuse".

Shlomo Shinnar, president of the American Epilepsy Society and a neurologist at Montefiore Medical Center in NY, has said the drug will be "a very valuable addition" to the limited options for treating severe childhood-onset epilepsy.

In three large clinical trials which the FDA considered before giving Epidiolex the official green light, researchers presented strong evidence that the pharmaceutical-grade CBD in the medicine had the power to significantly curb some of the worst symptoms of two of the hardest-to-treat forms of epilepsy, known as Lennox-Gastaut syndrome and Dravet syndrome. But thanks to a cannabis extract dubbed Charlotte's Web, Zaki's seizures all but stopped entirely. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care.

It won't cause a marijuana high and comes with side effects like tiredness, decreased appetite and diarrhea.

The agency, he added, remains concerned about "the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims".

According to GW Pharmaceuticals, the United States Drug Enforcement Administration (DEA) will have to reclassify CBD before Epidiolex can be made available to patients.

"This is the first time the government has approved a compound derived from the cannabis plant to treat any disorder - in this case, severe epilepsy due to Dravet and Lennox Gastaut syndromes".

"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", Devinsky said.

The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle. "And, the FDA is committed to this kind of careful scientific research and drug development", FDA Commissioner Scott Gottlieb, M.D, said.

While many of these developments remain in the early stages, the FDA's Epidiolex decision points to at least one concrete path ahead.

The FDA is not required to follow the advisory panel's advice but usually does.

While this move will undoubtedly increase profits for GW Pharmaceuticals, predicting annual sales eventually reaching $1 billion, it could also bring some much-needed relief to hundreds of thousands of children afflicted with more complex variations of epilepsy for which traditional treatments have been mostly ineffective.

GW said it expects the reclassifying to occur within 90 days.

The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education.