PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) recently reported encouraging data from its pivotal bioequivalence study for pitolisant gastro-resistant (GR), marking a major milestone as the company prepares to expand its narcolepsy portfolio.
The company said the study demonstrated that its new 17.8 mg GR formulation is bioequivalent to the currently approved 17.8 mg WAKIX tablets, with comparable AUC and Cmax ratios. Harmony added that no new safety or tolerability concerns emerged during the trial.
According to Harmony, the dosing optimization study delivered similarly strong results. All participants were able to begin treatment at the full therapeutic dose of 17.8 mg without titration, a feature the company believes will streamline therapy and improve patient experience.
“We are very pleased to have demonstrated bioequivalence for pitolisant GR which, along with the positive findings from our dosing optimization study, confirms its potential as a differentiated next-generation treatment option for narcolepsy patients,” said Kumar Budur, MD, MS, the company’s chief medical and scientific officer. He added that the GR coating and simplified dosing approach may support a more efficient treatment pathway.
With results from both studies now in hand, Harmony plans to file a New Drug Application for pitolisant GR in early 2026, targeting a PDUFA decision in the first quarter of 2027. The company has submitted utility patent applications covering pitolisant GR, which may extend market exclusivity to 2044.
Harmony is simultaneously progressing pitolisant HD, a higher-dose formulation intended to deliver enhanced therapeutic benefit for excessive daytime sleepiness and other lingering symptoms in narcolepsy and idiopathic hypersomnia. Patent applications for the HD version also extend to 2044, positioning the company for potentially long-term leadership in the sleep-wake therapeutics market.
Harmony said the expanding pitolisant franchise is approaching blockbuster potential, driven by continued innovation and increasing clinical demand.
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