In an FDA first, cannabinoid drug wins preliminary approval
Thursday, May 03, 2018
A medication containing cannabidiol, which is derived from marijuana plants, recently received preliminary approval from the Food and Drug Administration.
The approval for the product, Epidiolex, was given for the treatment of Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. This is the first drug that is derived from the cannabis plant to have received preliminary approval by the FDA.
Cannabidiol is not psychoactive and does not induce the high that those consuming plant marijuana products strive for.
The drug was reviewed by the Peripheral and Central Nervous System Drugs Advisory Committee, and the group was unanimous in voting for drug to move forward. The cannabidiol contained in Epidiolex has been shown to reduce the seizures associated with Dravet syndrome.
Orrin Devinsky, M.D., from the New York University Langone Comprehensive Epilepsy Center had testified before the committee advocating for the approval. Dr. Devinsky had done research in cannabidiol’s efficacy for the treatment of Dravet syndrome.
The syndrome is a rare genetic epileptic disorder that features seizures resistant to drug treatment and a high mortality rate. He found that those with Dravet syndrome achieved a lower rate of seizure and fewer adverse events when treated with cannabidiol.
Families with children suffering from Dravet syndrome also provided testimony before the committee.
The parents described the complexities of dealing with their children’s seizures. One father, Stephen Carlin provided videos of his daughter Zora. "She couldn’t go outside, she couldn’t do anything that other kids do," he explained.
But after receiving Epidiolex, "her seizures went from 40 to 50 a day to only a few or none per week," Carlin elaborated. Another parent discussed the inconsistent quality of existing products, with some products often having lower amounts of cannabidiol than stated and some having none at all. This was problematic when treating her child who has epilepsy.
The FDA has also had concerns about companies that produce cannabinoid products and take advantage of desperate families. FDA had identified and sent warning letters to companies making unsubstantiated medical claims and selling products that featured inappropriate identification of levels of cannabidiol. The agency sent out four such letters in 2017 and twenty-two in 2016.
The committee voting to approve Epidiolex acknowledged that there can be liver toxicity as a side effect, but felt that such complications could be managed. The committee did not discuss the concerns of intraocular pressure spiking that has been demonstrated in a rabbit model.
Epidiolex has now demonstrated the consistency and quality in production and final product that any other pharmaceutical-grade product must show to gain FDA approval. As a pharmaceutical-grade product, Epidiolex will give patients and their families more security and confidence in the treatment and management of the diseases for which it is approved.
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