Harmony Biosciences Reports the Initiation of P-III (INTUNE) Withdrawal Study for Pitolisant to Treat Idiopathic Hypersomnia
Shots:
- The P-III (INTUNE) withdrawal study evaluates pitolisant (selective H3 receptor/inverse agonist) vs PBO in ~200 patients with IH at 60 to 80 trial sites across the US
- The primary objective is to evaluate the efficacy & safety of pitolisant to treat EDS in adult patients with IH. The secondary objectives include the impact of pitolisant on other symptoms of IH while other outcomes include a patient impression of overall change in symptoms, investigator assessment of overall disease severity & functional status
- Pitolisant is marketed as Wakix in the US for EDS for cataplexy in adult patients with narcolepsy. The therapy also received ODD for narcolepsy & BTD for cataplexy
Ref: PRNewswire| Image:
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