FDA Approves Marijuana-Based Epilepsy Drug

FDA approves first cannabis-based drug

The approval was granted to Greenwich Biosciences, the U.S. subsidiary of GW Pharmaceuticals, for Epidiolex, an oral solution of purified cannabidiol (CBD).

This has always been a concern of Indiana Attorney General Curtis Hill, who has been outspoken against the use of marijuana and marijuana derivatives to treat illness in the past calling it a "gateway drug".

FDA commissioner Scott Gottlieb has said that it is committed to this kind of careful scientific research and drug development making these kinds of important medical advances.

The North American Marijuana Index closed mixed on Tuesday following this week's news that GW Pharmaceuticals (NASDAQ:GWPH) won FDA approval for their CBD-based drug Epidiolex. "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery". The FDA noted, however, that it will still "take action" against the illegal marketing of CBD-containing products with unproven medical claims.

Some adults with Angelman experience a type of myoclonic activity - involuntary muscle spams - that is not formally considered a seizure, but can cause debilitating tremors and muscle contractions, Bichell said. Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur.

Both Lennox-Gastaut syndrome and Dravet syndrome arise in childhood, often leading to development problems.

The article does not state exactly when the drug will be on the USA market, but generally, FDA approval coincides with market availability.

The FDA's approval of this drug is highly newsworthy and will be of great interest not only for those seeking help for the rare seizure disorders the new drug, Epidiolex, is meant to treat, but also for other diseases and symptoms such as pain and nausea. The drug was found to be effective in reducing the seizure frequency when taken with other medications as compared to placebo. Access is expected to be similar to other branded AEDs, and EPIDIOLEX® is expected to be available to appropriate patients by Fall 2018.

Dr. Shinnar believes the drug was carefully chosen, in light of the severe conditions it can help treat. Epidiolex may also cause liver injury, though generally mild. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition.

Currently, CBD-as with other marijuana components-is classified as a Schedule I drug by the DEA.

Rite Aid told CNNMoney it would sell Epidiolex once the DEA schedules it.

The FDA granted Priority Review designation for this application. The fast-track designation was granted for Dravet syndrome.

"The same principles around any prescription medication can now be applied to cannabis-based medications", GW Pharma Chief Executive Officer Justin Gover said in an interview before the FDA's decision.

At the CU Skaggs School of Pharmacy, there are now a few drugs being tested - one for seizures and the other for Parkinson's tremors that are both are derived from cannabis.

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