FDA Approves First Marijuana-Derived Drug

FDA approves first ever drug derived from marijuana | TheHill

First, the FDA must confer with the Drug Enforcement Administration to decide when to "reschedule" cannabidiol, better known as CBD, Devinsky said.

However, the CBD industry in the U.S.is also expected to grow in light of this summer's likely FDA approval of the first CBD-based drug, the epilepsy seizure medication Epidiolex, from British maker GW Pharmaceuticals (NASDAQ:GWPH).

Epidiolex is actually made by extracting the CBD molecule from cannabis plants and isolating it, Stephen Schultz, a spokesperson for GW Pharmaceuticals, which makes the drug, tells Yahoo Lifestyle.

Several parents of children with epilepsy testified before the panel, saying cannabidiol helped reduce seizures and improve quality of life. Where is weed legal?

That means that - just as with any other drug - as long as pharmaceutical companies can demonstrate they've subjected a marijuana-derived candidate to large, well-designed clinical trials, it has a fair chance of being seriously considered for approval by the FDA. "And, the FDA is committed to this kind of careful scientific research and drug development", Dr. Scott Gottlieb said in the statement. The agency is expected to do so within 90 days.

"Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", he said. Last year, the FDA sent warning letters to a number of CBD manufacturers, demanding that they cease making "unproven" claims that their medicines can fight cancer.

"It has shown in placebo trials it can reduce seizures in certain types of childhood-onset epilepsy and we believe it would a breakthrough in the U.S. and hopefully in the United Kingdom next year". Epidiolex contains only cannibidiol, one of hundreds of molecules found in the marijuana plant, and treats only two extremely rare forms of pediatric epilepsy affecting less than 45,000 children.

Epidiolex would also be the first approved therapy for DS, treatments for which are now limited to a combination of seizure medication and drugs to prevent emergencies.

Epidiolex's effectiveness was studied in three randomized clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome, comparing Epidiolex to a placebo.

The FDA news signals that the DEA will likely adjust its scheduling for CBD, which is now a Schedule I substance, denoting high potential for abuse and no medical applications.

Before sales of Epidiolex can begin, the DEA must formally reclassify CBD into a different category of drugs that have federal medical approval.

It's an option for those patients who have not responded to other treatments to control seizures. However, Schultz says his company plans to create more CBD medications.

Commenting on the agency's decision, NORML Deputy Director Paul Armentano said: "The FDA's approval of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis".

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

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