Harmony Biosciences Announces Plan to Begin Phase 3 Trial for Pitolisant Following Meeting with FDA

PWSA | USA received news from Harmony Biosciences that the company is working on a plan to begin their Phase 3 clinical trial for pitolisant, also known as WAKIX,  following a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration. WAKIX is an FDA approved drug used to treat excessive daytime sleepiness or cataplexy in adult patients with narcolepsy.

According to Harmony Biosciences press release announcement, Chief Medical Officer Kumar Budur, MD shared, "We are pleased with the outcome of our End-of-Phase 2 meeting with the FDA as we prepare to initiate our Phase 3 registrational study, which aims to further investigate the efficacy and safety of pitolisant as a potential treatment for excessive daytime sleepiness in individuals with Prader-Willi syndrome. Building upon the encouraging data obtained from our Phase 2 signal detection study, we remain committed to advancing our development program for pitolisant in pursuit of a new indication in people with PWS, given the high unmet medical need in this population.”

Find Harmony Biosciences' full press release announcement at the button below, which includes more details from their meeting with the FDA and next steps for the Phase 3 study.

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