FDA Regulatory Panel Recommends CBD Drug Approval

On April 19th, the U.S. Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously to recommend that the FDA approve a new cannabidiol epilepsy drug called Epidiolex. This drug, which is taken as an oral liquid, is intended to help people with severe forms of epilepsy. The FDA will vote in June on whether or not to approve the new medication.

Epidiolex was developed by GW Pharmaceuticals PLC, a biopharmaceutical corporation based in the United Kingdom. The drug is most specifically aimed at adults and children who suffer from Lennox-Gestaut syndrome or Dravet syndrome. Both these conditions are lifelong disorders that first strike patients when they’re children; the seizures they cause are extremely debilitating. According to the Epilepsy Foundation, about a third of all patients who suffer from epilepsy do not find relief from existing drugs and therapies.

16-year-old epilepsy patient Sam Vogelstein of Berkeley, California testified at the hearing about Epidiolex’s effectiveness.

“I had seizures for 10 years,” he told the committee. “My parents tell me there were times I had seizures 100 times a day.” He stated that he started taking Epidiolex in 2013. “I’ve been seizure-free for more than two years now. It changed my life.”

Industry observers do expect that the FDA will approve the drug in June.

 

 

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