The first cannabinoid prescription in the US has been given the green light by the US Food and Drug Administration (FDA) [June 25 2018].
GW Pharmaceuticals’ Epidiolex has been approved to treat two rare forms of childhood onset epilepsy – Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome.
FDA commissioner Scott Gottlieb 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. And the FDA is committed to this kind of careful scientific research and drug development.”
Justin Gover, GW’s chief executive officer, described the approval as “a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe childhood-onset epilepsies”.
He added: “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.”
The Epidiolexclinical development programme included three randomized, controlled Phase 3 clinical trials and an open-label extension study. In the Phase 3 studies, published in The New England Journal of Medicine[1],[2] and Lancet [3],researchers found Epidiolexadded to other antiepileptic therapies significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.
“For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolexrepresents a true medical advancement,”said Philip Gattone, president and CEO of the Epilepsy Foundation.
He said the FDA’s endorsement “brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures”.
References
[1] Devinsky O, Cross JH, Laux L, et al. Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med 2017;376;2011-20.
[2] Devinsky O, Patel AD, Cross JH, et al. Effect of Cannabidiol on Drop Seizures in the Lennox–Gastaut Syndrome. N Engl J Med 2018;378;20:1888-97.
[3] Thiele EA, Marsh ED, French JA, et al. Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomized, double-blind placebo-controlled phase 3 trial. Published online January 24, 2018 http://dx.doi.org/10.1016/S0140-6736(18)30136-3.
