Harmony Biosciences Initiates TEMPO PWS Study

Harmony Biosciences Holdings, Inc. is seeking participants for its TEMPO study, a global Phase 3 trial investigating pitolisant as a potential treatment for excessive daytime sleepiness (EDS) in individuals aged six years and older with Prader-Willi syndrome (PWS). Pitolisant is a medication that could help manage sleepiness and behavioral issues in people with PWS.

There are seven (7) trial sites currently open and accepting patients:

This study comes after a successful meeting between Harmony Biosciences and the FDA. As a result of the meeting, Harmony received Orphan Drug Designation (ODD) for pitolisant in PWS, which means the treatment is recognized as important for a rare condition like PWS. Being part of this trial could help bring a new treatment option to those living with PWS, as there are currently no FDA-approved medications specifically for daytime sleepiness in PWS.

Dr. Kumar Budur, Chief Medical Officer of Harmony Biosciences, is excited about the potential of pitolisant to address the needs of people with PWS. 

If your loved one living with PWS experiences daytime sleepiness or behavioral symptoms, participating in this trial could help advance research and potentially bring a new treatment option to the community. 

To read Harmony Biosciences full press release announcement, please click the button below.

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