Avadel receives orphan drug designation for FT 218 for narcolepsy

Avadel Pharmaceuticals (AVDL) announced that FT 218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration 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 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.

Narcolepsy is a debilitating and rare sleep disorder for which limited treatment options exist. We look forward to completing our REST-ON Phase III trial this year and are hopeful that FT 218 can provide meaningful benefit to patients and their quality of life over other standards of care.”

Narcolepsy is a long-term neurological disorder that involves a decreased ability to regulate sleep-wake cycles. Symptoms include periods of excessive daytime sleepiness that usually last from seconds to minutes and may occur at any time. About 70% of those affected also experience episodes of sudden loss of muscle strength, known as cataplexy. These spells can be brought on by strong emotions. Less commonly there may be inability to move or vivid hallucinations while falling asleep or waking up.[1] People with narcolepsy tend to sleep about the same number of hours per day as people without, but the quality of sleep tends to be worse.

AVDL closed at $9.10, it last traded at $9.86.

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