Harmony completes End-of-Phase 2 meeting with FDA for pitolisant

Harmony Biosciences Holdings has successfully completed an End-of-Phase 2 meeting with FDA regarding its clinical development plan evaluating pitolisant as a potential treatment for excessive daytime sleepiness, or EDS, in patients ages six and older with Prader-Willi syndrome, or PWS. Harmony plans to initiate a Phase 3 registrational study in the Q4. Based on a positive signal observed from the Phase 2 proof-of-concept study, Harmony aligned with the FDA on the proposed Phase 3 study design elements to support further investigation of pitolisant for children, adolescents and adults with PWS experiencing EDS. There is currently no FDA-approved treatment for EDS in this patient population.