11:05 AM EDT, 04/03/2024 (MT Newswires) -- Harmony Biosciences ( HRMY ) said Wednesday it has started the global phase 3 registrational trial of pitolisant to treat excessive daytime sleepiness and behavioral symptoms in patients aged six years and older with Prader-Willi syndrome.

The company said the study aims to assess the safety and effectiveness of pitolisant, which was earlier granted Orphan Drug Designation in PWS by the US Food and Drug Administration.

Pitolisant is approved in the US to treat EDS or cataplexy in adults with narcolepsy, the company said.

Harmony Biosciences ( HRMY ) shares were up 1.7% in recent Wednesday trading.

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