EPIDIOLEX, which was approved by the U.S. Food and Drug Administration (FDA) on June 25, 2018, is the first prescription pharmaceutical formulation of highly purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs.
GW Pharmaceuticals CEO Justin Gover said: “We are delighted to announce that EPIDIOLEX is now available by physician prescription as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy.
“Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures.
“We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”
The company has introduced a comprehensive patient support program called EPIDIOLEX Engage, which is designed to help patients who have been prescribed EPIDIOLEX gain access to therapy.
The program offers patient/caregiver-focused education and resources to help lower out-of-pocket costs or provide product at no cost for eligible patients.
Lennox-Gastaut Syndrome Foundation executive director Christina SanInocencio said: “EPIDIOLEX is a much-needed new treatment option for patients with LGS, a rare and severe form of childhood-onset epilepsy that typically persists into adulthood.
“Despite the use of multiple epilepsy treatments, the majority of LGS patients continue to have life-long, debilitating seizures and our community welcomes the availability of a new, first-in-class treatment option.”
Dravet Syndrome Foundation executive director Mary Anne Meskis said: “We are very pleased that EPIDIOLEX — the first medication to be approved by the FDA for patients with Dravet syndrome — is now available.
“Our community has long desired a medication specifically approved for the treatment of seizures associated with Dravet syndrome, and the availability of EPIDIOLEX is an important milestone for patients and caregivers whose lives are significantly impacted by this catastrophic, lifelong form of epilepsy.”
The EPIDIOLEX clinical development program included three randomized, controlled Phase 3 clinical trials and an open-label extension study. The Phase 3 studies have been published in The New England Journal of Medicine and Lancet.
EPIDIOLEX added to other antiepileptic therapies significantly reduced the frequency of drop seizures in patients with LGS and convulsive seizures in patients with Dravet syndrome.
The most common adverse reactions that occurred in EPIDIOLEX-treated patients were somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor quality sleep; and infections.
The company’s development program represents the only well-controlled clinical development program of a cannabinoid medication leading to FDA approval for patients with LGS and Dravet syndrome.
Source: Company Press Release