The FDA approves privately held Harmony Biosciences, LLC’s WAKIX (pitolisant) for the treatment of excessive daytime sleepiness in adult patients with narcolepsy.
Commercial launch of the histamine 3 receptor antagonist/inverse agonist will commence next quarter.
Endo International (NASDAQ:ENDP) has commercial rights in Canada.
The product will compete directly with Jazz Pharmaceuticals’ (NASDAQ:JAZZ) XYREM (sodium oxybate) approved in the U.S. in 2005 for the indication. The central nervous system depressant accounted for 77% of the company’s Q2 revenues.
Shares are down a fraction premarket.
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