SOURCE: INSYS Therapeutics PHOENIX, AZ--(Marketwired - Feb 26, 2015) - Insys Therapeutics, Inc. (NASDAQ: INSY) today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to its pharmaceutical cannabidiol ("CBD") formulation for the treatment of Dravet syndrome, a rare form of childhood epilepsy. FDA's Fast Track program facilitates the development and review of drugs intended to treat serious conditions and address an unmet medical need.A drug development program with Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval to get important new drugs to the patient earlier. "Coupled with our candidate's orphan drug designation in Dravet syndrome, Fast Track designation represents significant additional support of our goal of addressing the significant medical need of children suffering from this rare and catastrophic treatment-resistant form of pediatric epilepsy," said Michael L. Babich, President and Chief Executive Officer of Insys."Rapid advancement of our pharmaceutical CBD program is a key priority for Insys, and we are pleased to be initiating clinical trials with this program in 2015.These include a Phase I/pharmacokinetic study in epilepsy patients and a Phase III clinical trial in patients suffering from Dravet … Continue reading
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