Epidiolex Now Available in the U.S. for Lennox-Gastaut and Dravet Patients 2 and Older
Epidiolex (cannabidiol) oral solution is now available in the United States as a treatment for seizures in patients age 2 or older who have Lennox-Gastaut syndrome or Dravet syndrome.
Epidiolex is developed by GW Pharmaceuticals and will be marketed in the U.S. by its subsidiary, Greenwich Biosciences.
The anti-epileptic therapy is a purified form of cannabidiol (CBD), the most abundant non-psychoactive cannabinoid compound in the cannabis plant. CBD can mimic natural compounds that act on brain receptors, which when faulty can cause seizures.
“We are delighted to announce that Epidolex 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,” Justin Gover, chief executive officer of GW Pharmaceuticals, said in a press release.
“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,” he said.
To support patients’ access to the therapy, GW Pharmaceuticals launched a program — Epidolex Engage — that offers guided resources for patients and caregivers, helping those with financial constraints get access to the therapy. Also, eligible patients may have access to the product at no cost.
“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,” Gover said.
The U.S. Food and Drug Administration (FDA) approved Epidiolex on June 25, 2018.
The Epidiolex clinical development program included three randomized, controlled Phase 3 clinical trials (NCT02091375, NCT02224703 and NCT02224560) and an open-label extension study (NCT02224573).
The extension study evaluated the long-term safety and effectiveness of Epidiolex and included 189 Dravet patients from two of the previous Phase 3 trials. Results showed that treatment with Epidiolex reduced convulsive seizures by 38-44% and all seizures by 39-51%.
Treatment also improved overall health and clinical status in roughly 80% of patients at six months and one year of treatment.
“We are very pleased that Epidolex — 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 Epidolex is an important milestone for patients and caregivers whose lives are significantly impacted by this catastrophic, lifelong form of epilepsy.”
The therapies available to patients with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy, are also limited.
“Epidolex is a much-needed new treatment option for patients with LGS,” 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 lifelong, debilitating seizures and our community welcomes the availability of a new, first-in-class treatment option,” she said.
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