A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
Latest Information Update: 20 Jan 2025
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At a glance
- Drugs Pitolisant (Primary)
- Indications Idiopathic hypersomnia
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms INTUNE
- Sponsors Harmony Biosciences
- 13 Jan 2025 According to Harmony Biosciences Holdings media release, FDA Decision on file acceptance of Pitolisant sNDA for Idiopathic Hypersomnia to be in Q1 2025.
- 29 Oct 2024 According to Harmony Biosciences Holdings media release, company is On Track to Submit sNDA for Pitolisant in Idiopathic Hypersomnia (IH) in Q4 2024.
- 30 Apr 2024 According to a Harmony Biosciences media release, the company plans to submit supplemental new drug application (sNDA) for pitolisant in Idiopathic Hypersomnia in the second half of 2024