FDA clears CBD-based epilepsy drug Epidiolex
The Food and Drug Administration has approved a new epilepsy treatment, marking the first approval of a drug whose active ingredient is a purified drug substance derived from marijuana. Epidiolex (cannabidiol, or CBD, oral solution) is indicated to treat two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years old and older.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA commissioner Scott Gottlieb said. “And, the FDA is committed to this kind of careful scientific research and drug development. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA's drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.
CBD is not the primary psychoactive component of marijuana, the FDA said. Gottlieb noted that the agency would continue to support research on potential medical uses of marijuana-derived products while combatting illegal marketing of CBD products with unproven medical claims. “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.
For the patients whose seizures are treated by Epidiolex — developed by U.K.-based GW Pharmaceuticals — the drug has potential to impact their lives, according to FDA officials.
“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life," said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition."
Epidiolex will be marketed by Greenwich Biosciences, GW Pharmaceuticals’ U.S. subsidiary. Before being made available for patients, the drug has to be rescheduled from its current Schedule I status, which the company anticipates in the next 90 days, with the company projecting a Fall availability.
“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,” GW CEO Justin Grover said.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA commissioner Scott Gottlieb said. “And, the FDA is committed to this kind of careful scientific research and drug development. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA's drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.
CBD is not the primary psychoactive component of marijuana, the FDA said. Gottlieb noted that the agency would continue to support research on potential medical uses of marijuana-derived products while combatting illegal marketing of CBD products with unproven medical claims. “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.
For the patients whose seizures are treated by Epidiolex — developed by U.K.-based GW Pharmaceuticals — the drug has potential to impact their lives, according to FDA officials.
“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life," said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition."
Epidiolex will be marketed by Greenwich Biosciences, GW Pharmaceuticals’ U.S. subsidiary. Before being made available for patients, the drug has to be rescheduled from its current Schedule I status, which the company anticipates in the next 90 days, with the company projecting a Fall availability.
“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,” GW CEO Justin Grover said.