EPIDIOLEX the First Plant-derived Cannabinoid Prescription Medicine - Receives FDA Approval for Dravet Syndrome and Lennox Gastaut Syndrome
CHERRY HILL, N.J. (PRWEB) June 27, 2018 -- The Dravet Syndrome Foundation is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved EPIDIOLEX® (cannabidiol /CBD) for the treatment of seizures associated with Dravet syndrome Lennox-Gastaut Syndrome (LGS) in patients two years age or older. EPIDIOLEX® is the first prescription pharmaceutical formulation of highly-purified CBD and the first in its class of anti-epileptic drugs.
“We are very pleased to see the approval of EPIDIOLEX® for Dravet and Lennox-Gastaut Syndromes, says Dravet Syndrome Foundation executive director Mary Anne Meskis. “While each of our disorders are different in terms of etiology, both of our communities suffer from intractable seizures, an increased risk of mortality, and many devastating co-morbid conditions that significantly affect quality of life.”
Along with the FDA’s approval for EPIDIOLEX® for seizures associated with Dravet Syndrome, the approval is also indicated for another form of rare epilepsy that begins in childhood called Lennox-Gastaut syndrome.
“Today’s announcement gives individuals with Lennox-Gastaut Syndrome and their families much-needed hope,” says LGS Foundation executive director, Christina SanInocencio. “Lennox-Gastaut Syndrome is a devastating form of epilepsy, and despite currently available FDA-approved medications and a poly-therapy approach to treatment, the majority of individuals with LGS will continue to have life-long, debilitating seizures, along with cognitive impairment and an abnormal brain waves on EEG (electroencephalogram).”
The EPIDIOLEX® clinical development program included three randomized, controlled Phase 3 clinical trials and an open-label extension study. In the Phase 3 published studies, EPIDIOLEX® added to other antiepileptic therapies significantly reduced the frequency of seizures in patients with Dravet Syndrome and LGS. The company’s development program represents the only well-controlled clinical evaluation of a cannabinoid medication for patients with LGS and Dravet Syndrome.
Rescheduling by the DEA is expected to occur within 90 days. Access is expected to be similar to other branded AEDs, and EPIDIOLEX® is expected to be available to appropriate patients by Fall 2018. Outside the U.S., this medicine is currently under review by the European Medicines Agency (EMA) for the treatment of seizures associated with Dravet Syndrome and LGS. An EMA decision on whether to recommend approval is expected in the first quarter of 2019.
About the Dravet Syndrome Foundation
The Dravet Syndrome Foundation is a non-profit organization whose mission is to aggressively raise research funds for Dravet syndrome and related epilepsies; to increase awareness of these catastrophic conditions; and to provide support to affected individuals and families.
Mary Anne Meskis, Dravet Syndrome Foundation, http://www.dravetfoundation.org, +1 (203) 392-1950, [email protected]
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