11/16/2018 - Posted in  Pharmaceutical Affairs

FDA approves first marijuana-based drug

Our expert's opinion

"GW Pharmaceuticals, a british company, is developping, producing and now distributing the first FDA approved drug that is derived from marijuana. This drug, called EPIODIOLEX®, is made of highly purified cannabidiol (CBD) and thus does not contain THC. It is in the form of a stawberry-flavored syrup and it’s effect reduces seizures in 2 specific cases of epilepsy. Epiodiolex has been approved by the FDA and is now legal and available in the U.S., with a prescription from a doctor.

Even though it will help a lot of people, it still can cause unpleasant symptoms, such as sleepiness, loss of appetite, diarrhea or even anxiety and suicidal thoughts. A request for Marketing Authorization Application has been sent to the European Medical Agency and the decision should fall around March 2019. What is your opinion on a medicine based on Marijuana?"

- Antoine Desprez, Associate Consultant

EPIDIOLEX® (cannabidiol) Oral Solution – the First FDA-approved Plant-derived Cannabinoid Medicine – Now Available by Prescription in the U.S.

LONDON and CARLSBAD, Calif., Nov. 01, 2018 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), the world leader in the development and commercialization of cannabinoid prescription medicines, along with its U.S. subsidiary Greenwich Biosciences, announced today that EPIDIOLEX® (cannabidiol) oral solution CV is now available in the U.S. 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.”

“We are very pleased that EPIDIOLEX -- the first medication to be approved by the FDA for patients with Dravet syndrome -- is now available,” said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation. “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 Medicine1,[2] and Lancet3. 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.

EPIDIOLEX was developed by GW Pharmaceuticals and will be marketed in the U.S. by its subsidiary, Greenwich Biosciences. For more information on EPIDIOLEX, visit www.EPIDIOLEX.com.

About EPIDIOLEX® (cannabidiol) oral solution

EPIDIOLEX, the first prescription, plant-derived cannabinoid medicine in the United States 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. GW has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for EPIDIOLEX with an expected decision date in the first quarter of 2019. 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 currently conducting an additional Phase 3 clinical development program in the treatment of seizures associated with TSC.

Source: ir.gwpharm.com

Other insights in Pharmaceutical Affairs