Harmony Biosciences to Submit NDA for Narcolepsy Treatment Following Trial Results

MT Newswires Live11-24

Harmony Biosciences (HRMY) said Monday that it expects to submit a New Drug Application to the US Food and Drug Administration in early 2026 for gastro-resistant Wakix (pitolisant GR) to treat narcolepsy.

The pharmaceutical company said the evaluation is based on a pivotal bioequivalence study, which it said confirmed that the 17.8mg dose of the gastro-resistant drug is bioequivalent to existing 17.8mg Wakix tablets.

Harmony also reported that there were no new safety or tolerability issues, and that topline data from the dosing optimization study of Wakix showed that 100% of patients successfully initiated treatment at the therapeutic dose of 17.8mg, which eliminated the need for dose titration.

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