United States approves Epidiolex, first marijuana-derived drug

Epidiolex a medicine made from the marijuana plant but without THC

The FDA paid attention, and Monday approved Epidiolex, the first-ever prescription drug derived from marijuana.

The drug, Epidiolex, is made up of cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high.

Treatments available for both disorders are far from ideal and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said.

Earlier this year, an FDA advisory panel unanimously recommended that the FDA approve Epidiolex, in large part due to strong research data and evidence of the drug's effectiveness in controlling the violent drop seizures that accompany two rare forms of childhood epilepsy. 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. Carreno says that once the drug is descheduled, CBD manufacturers must register with the DEA-and that will make all the difference to the industry in the U.S.

"This is an important medical advance", FDA Commissioner Dr. Scott Gottlieb said in a statement Monday.

He added, "This is how sound medical science is advanced".

The FDA took pains to specify that clearing Epidiolex for use is not an approval of marijuana or any of its components. "This is the approval of one specific CBD medication for a specific use", Gottlieb said.

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The goal is have it available in pharmacies by the end of the year, said Orrin Devinsky, a pediatric neurologist and director of the New York University-Langone and Saint Barnabas Comprehensive Epilepsy Center in Livingston, who co-authored the research.

A total of 225 patients suffering from Lennox-Gastaut syndrome were divided into three groups. But GW said it expects that the DEA will reschedule CBD within 90 days. Other companies working with cannabidiol include AXIM Biotechnologies and Cure Pharmaceutical.

Epidiolex, manufactured by GW Pharmaceuticals, is meant to treat seizures associated with two rare and severe forms of epilepsy.

Prior approval has been granted for medicines derived from synthetic cannabinoids.

Based on the potential for abuse, the Drug Enforcement Administration (DEA) categorizes chemicals into five schedules, with Schedule 1 substances - like marijuana and heroin - considered the most deadly, and deemed to have no medical benefit whatsoever.

Epidiolex is also the first prescription created to treat children with Dravet syndrome, according to the FDA's announcement. She is cautiously optimistic about FDA approval of Epidiolex, the first drug made of CBD.

The FDA's decision was not unexpected, as the proprietary extract formulation - developed by the British biotechnology firm GW Pharmaceuticals - had previously demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials.

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