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GW Pharmaceuticals says first FDA approved cannabinoid medicine now available by prescription in US

The CBD-based drug will be used against two of the most difficult-to-treat forms of childhood-onset epilepsy
Vials containing THC and CBD oils
GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas.

GW Pharmaceuticals PLC (NASDAQ:GWP) announced on Thursday that Epidiolex, a cannabidiol oral medication for the treatment of seizures, is now available through a prescription in the United States.

It is the first pharmaceutical formulation of a highly purified, plant-derived cannabidiol (CBD), a cannabinoid that lacks the high associated with marijuana, and is the first in a new category of anti-epileptic drugs. Epidiolex is an oral solution for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. The drug was approved by the US Food and Drug Administration (FDA) on June 25, 2018, 

“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, the CEO 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,” he added.

READ: How the DEA’s new stance on GW Pharma’s epilepsy drug can energize the cannabis industry and help patients

The company has introduced a comprehensive patient support program designed to help patients who have been prescribed Epidiolex gain access to the 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. 

“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.”

The drug was developed by GW Pharmaceuticals and will be marketed in the US by its subsidiary, Greenwich Biosciences. 

GW Pharmaceuticals has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the drug, with an expected decision date due in the first quarter of 2019.

READ: GW Pharmaceuticals’cannabis drug for epilepsy coming to market faster after DEA lowers CBD restriction

GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of seizures associated with tuberous sclerosis complex (TSC). The company has also received Orphan Designation from the EMA for Epidiolex for the treatment of seizures associated with LGS, Dravet syndrome, and TSC.

GW is also currently conducting an additional Phase 3 clinical development program in the treatment of seizures associated with TSC.

GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas.

Reporting by Rene Pastor, contactable on [email protected]

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