FDA Approves Country’s First Cannabis Extract-Based Pharmaceutical

The Food and Drug Administration today approved the country’s first pharmaceutical drug containing only a pure extract from the cannabis plant. Until now, only synthetic cannabinoid-based medicines have been approved.

The news of the approval of GW Pharmaceuticals’ Epidiolex, which contains only the non-psychoactive cannabinoid CBD (cannabidiol), was expected for months after clinical trials wrapped up on its potential for patients with rare and severe forms of epilepsy. The FDA approval could have much wider implications for both patients in need of CBD-based medications, and for the cannabis industry, because of off-label use, which may be permitted.

“From the FDA’s perspective, with a few exceptions, health care professionals generally may choose to prescribe or use a legally marketed human drug for an unapproved use when they judge that the off-label use is medically appropriate for an individual patient,” Sandy Walsh, a spokesperson for the FDA told Cannabis Wire. But, there are exceptions, because “statutes and legal requirements” handed down by agencies other than the FDA might govern prescriptions of Epidiolex, “including, but not limited to, the Controlled Substances Act and state medical licensing and practice requirements.” Walsh emphasized that approval for one use does not indicate efficacy or safety for another.

Justin Gover, GW Pharmaceuticals’ CEO said in a statement that the approval of Epidiolex was “a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.” Families of sick children living in states without legal access to CBD have traveled or relocated to states like Colorado to obtain CBD-rich oil; soon, it will be available from their neighborhood pharmacy.

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Epidiolex cannot be distributed to pharmacies across the country until the DEA reschedules CBD, Walsh said. GW Pharmaceuticals said in a statement that they expect rescheduling within 90 days, and for Epidiolex to be available to patients by fall 2018. The process begins with the FDA recommendation that CBD be rescheduled (which happens alongside the National Institute on Drug Abuse), then moves through the Department of Health and Human Services, before landing on the DEA’s desk. On April 19, the “FDA’s Controlled Substances Staff concluded that CBD, as a highly purified drug substance, does not appear to have meaningful abuse potential,” Walsh said.

It remains unclear what the FDA approval of Epidiolex, or rescheduling of pure CBD, could mean for unregulated preparations of CBD already being sold and shipped across the country. The Drug Enforcement Administration did not responded to requests for comment by time of publication. In a statement, FDA Commissioner Scott Gottlieb acknowledged unlawful sales of CBD products: “We are prepared to take action when we see the illegal marketing of CBD-containing products with serious, 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,” Gottlieb said.

When it comes to CBD, the writing has been on the wall for years. In 2014, the FDA fast-tracked clinical trials after strong interest from families and lawmakers to make cannabidiol (CBD)-based products available to children with intractable forms of epilepsy, or seizures that generally do not respond to other medications. In 2015, Nora Volkow, the director of the National Institute on Drug Abuse, wrote a blog post called “Researching Marijuana for Therapeutic Purposes: The Potential Promise of Cannabidiol (CBD).” And, finally, today’s FDA news comes just weeks after the World Health Organization (WHO) Critical Review Report on cannabidiol (CBD) found that CBD “exhibits no effects indicative of any abuse or dependence potential.”

When asked if any other plant-derived medications were in the FDA pipeline for approval, Walsh told Cannabis Wire “We cannot discuss other potential applications or products under development.”

GW Pharmaceuticals said in a statement that the company has other cannabinoid-based products in Phase 1 and 2 trials for epilepsy, glioblastoma, and schizophrenia.  

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