Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for FT 218 for the Treatment of Narcolepsy
Avadel Pharmaceuticals plc - Ordinary Share (AVDL)
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Source: GlobeNewswire
DUBLIN, Ireland, Jan. 10, 2018 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), “Avadel” or “the Company,” today announced that FT 218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. FT 218, a once-nightly formulation of sodium oxybate using Avadel’s proprietary Micropump® technology, is currently undergoing testing in a Phase III clinical trial for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. The designation has been granted on the plausible hypothesis that FT 218 may be clinically superior to the same drug already approved for the same indication because FT 218 may be safer due to ramifications associated with the dosing regimen of the previously-approved product. Mike Anderson, Avadel’s Chief Executive Officer, said, “Receipt of Orphan Drug Designation for FT 218 is meaningful for both Avadel and patients suffering from Narcolepsy. N
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