FDA Approves Cannabis-Derived Drug for First Time
June 25th, 2018
In a move destined to potentially change the face of medical cannabis, the United States Food and Drug Administration (FDA) today approved a cannabinoid-derived drug for the first time. Epidiolex is a twice-daily oral solution is meant to treat people ages two years and up who suffer from severe seizure disorders Dravet syndrome or Lennox-Gastaut syndrome. An FDA advisory committee recommended the drug for approval in April.
“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,” said Justin Gover, CEO of GW Pharmaceuticals (NASDAQ: GWPH), makers of the drug, in a statement. “This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”
Epidiolex will hit the market in October and is expected to be a blockbuster drug. In clinical trials, the medication was shown to reduce seizures by about 40 percent. While only approved to treat two forms of epilepsy, it is possible Epidiolex will be prescribed “off-label” for other conditions.
“This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies,” FDA Commissioner Scott Gottlieb said in a statement today adding the approval was “an important medical advance.”
“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,” said Orrin Devinsky, M.D., of NYU Langone Health’s Comprehensive Epilepsy Center and a lead investigator in the Epidiolex clinical program. “I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults.”
Now that the FDA has approved Epidiolex, the US Drug Enforcement Agency (DEA) will have 90 days to reschedule CBD, the non-psychoactive cannabinoid responsible for the medication’s effects. Currently, CBD is a Schedule I narcotic with “no known medical benefit.” The move is expected to have huge implications for the CBD market nationwide, which currently operates in a legal gray area.
“We don’t have a choice on that,” DEA public affairs officer Barbara Carreno said in an interview with Business Insider. “It absolutely has to become Schedule 2 or 3.”
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