USA approves first marijuana-based medicine

USA approves first marijuana-based medicine

The US Food and Drug Administration announced today, Monday June 25, the approval of the country's first marijuana-based prescription medication.

Nasdaq-listed GW Pharmaceuticals, which grows its own marijuana plants in glass houses in Britain, hopes the drug will be approved in the United Kingdom next year.

The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption.

Two months after a unanimous recommendation by an outside group of FDA experts and some glowing recommendations in the internal review, GW will now set out to open up a new class of meds after demonstrating the drug's ability to prevent seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome. In clinical trials, patients administered Epidiolex, on average, obtained a 40 percent reduction in seizure frequency.

"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. It also marks a landmark moment in the agency's advancement in considering cannabis for medical purposes.

Gottlieb noted that the action was "not an approval of marijuana or all of its components" but rather of one specific CBD medication for a particular use. The new drug is anticipated to become available to patients later this fall. Similar results were reported in a Phase 3 placebo-controlled trial among 171 patients with Lennox-Gastaut syndrome published this year in the Lancet. But GW said it expects that the DEA will reschedule CBD within 90 days.

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USA 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 drug has been shown to reduce seizures and return a few children to near-normal function. The agency has previously approved drugs made from synthetic versions of THC and other marijuana constituents. Marijuana and its components, including CBD, are Schedule 1 controlled substances - meaning they are banned because they are thought to have a high abuse potential, no medical value and serious safety implications.

First, the FDA must confer with the Drug Enforcement Administration to decide when to "reschedule" cannabidiol, better known as CBD, Devinsky said. Other companies working with cannabidiol include AXIM Biotechnologies and Cure Pharmaceutical.

"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.

In April, an advisory committee to the FDA voted unanimously that the risk-benefit profile for Epidiolex was favorable. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. For instance, 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.

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