PDM Healthcare Health Industry Link - Volume 7, Issue 5

EPIDIOLEX® (cannabidiol) Oral Solution – the First FDA-approved Plant-derived Cannabinoid Medicine

GW is committed to developing new medicines to treat rare, treatment-resistant epilepsy conditions where there are limited or in some cases, no approved treatment options.

Cannabidiol (approved as Epidiolex in the United States) is GW’s lead cannabinoid product is a proprietary oral solution of highly purified plant-derived cannabidiol, or CBD. GW’s Epidiolex development has initially concentrated on two severe, orphan, early-onset, treatment-resistant epilepsy syndromes – including Dravet syndrome, Lennox-Gastaut syndrome (LGS) – and is in Phase 3 trials for Tuberous Sclerosis Complex (TSC).

Epidiolex, the first prescription, plant-derived cannabinoid medicine in the United Staes and the first in a new class of anti-epileptic medications, is a pharmaceutical formulation of highly purified cannabidiol (CBD) now FDA approved for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. 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.

“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,” said Justin Gover, Chief Executive Officer of GW Pharmaceuticals. “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. More information can be found at EPIDIOLEX.com.

“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,” said Christina SanInocencio, Executive Director of the Lennox-Gastaut Syndrome Foundation. “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.”

Source: https://www.gwpharm.com/healthcare-professionals/epidiolex



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