FDA Approves First Marijuana-Derived Drug

FDA approves first ever drug derived from marijuana | TheHill

USA health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

Dravet syndrome is a rare genetic condition that causes frequent fever-related seizures, involuntary muscle spasms and a potentially life-threatening state of continuous seizure activity requiring emergency medical care. Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex is the first licensed to treat Dravet syndrome.

"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 that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes", Gottlieb said.

"Sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", FDA Commissioner Dr. Scott Gottlieb said in a statement released Monday by the agency.

He said there are thousands of parents with children having daily seizures who want all medical treatments explored, even those involving cannabis.

The FDA took pains to specify that clearing Epidiolex for use is not an approval of marijuana or any of its components. Almost all patients with these conditions continue to have daily seizures-some having multiple per day-despite the use of legally available drugs. Similar results were reported in a Phase 3 placebo-controlled trial among 171 patients with Lennox-Gastaut syndrome published this year in the Lancet.

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Federal agencies have 90 days to determine the scheduling of Epidiolex.

But although the green light means that patients will soon be able to access Epidiolex with a doctor's prescription, many will also likely turn to less expensive sources of CBD, such as those sold in marijuana dispensaries.

Today's approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others", the FDA said. But marijuana products in general are subject to Schedule I restrictions by the Drug Enforcement Administration (DEA) because of the potential for abuse.

A new drug derived from marijuana just became the first of its kind to get the green light from the USA government. "However, it remains to be seen whether physicians will be comfortable prescribing this new agent to those patients who may benefit from it, and whether it will be priced in a range that patients may afford". Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. And like other drugs that treat epilepsy, Epidiolex will come with a special warning that use may be tied to a higher odds of depression, aggression and suicidal thoughts.

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