Epidiolex®, an “investigational cannabidiol product” developed by GW Pharmaceuticals, has received Fast Track designation from FDA for the treatment of Dravet syndrome – a rare, treatment-resistant form of epilepsy. FDA’s Fast Track program facilitates the development and review of drugs intended to treat serious conditions and to fill an unmet medical need. Fast-tracked drug development programs may receive greater access to FDA for the purpose of expediting development, review, and potential approval to ensure that potentially important drugs get to patients as quickly as possible, when safe. In a press release, GW Pharmaceuticals also announced plans to conduct a clinical development program for the use of Epidiolex to treat Lennox-Gastaut Syndrome.
If approved, such cannabinoidal medications could affect state medical marijuana laws and programs. Currently, 22 states and the District of Columbia have laws to create medical marijuana programs. At NABP’s 110th Annual Meeting, a continuing pharmacy education session provided a legislative update on medical marijuana laws and their potential impact on pharmacy practice and regulation.
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