Harmony Advances Pitolisant GR After Bioequivalence Success
Positive trial results position the next-generation pitolisant formulation for a New Drug Application in early 2026.
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FDA Approves Non-Scheduled Narcolepsy Drug for Children
The FDA has expanded the approval of a narcolepsy drug, previously approved for adults, to now include children aged 6 and older.
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Harmony Gets FDA Orphan Drug Designation for Pitolisant for Idiopathic Hypersomnia
Harmony Biosciences is currently evaluating the efficacy and safety of pitolisant in adult patients with idiopathic hypersomnia in a phase 3 study, with topline results anticipated in the fourth quarter.
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Wakix Patent Challenge Rejected by US Patent Office  
The United States Patent and Trademark Office has denied a Petition for Reexamination concerning a patent covering the active ingredient in Wakix (pitolisant).Â
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Harmony to Begin Phase 3 Study of Pitolisant for Prader-Willi Syndrome
The study will further investigate pitolisant in children, adolescents, and adults with Prader-Willi syndrome experiencing excessive daytime sleepiness.
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Pitolisant Receives Approval in China for Narcolepsy Treatment
The approval makes pitolisant the first and only treatment drug approved in mainland China for narcolepsy.
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Harmony Announces Positive Phase 2 Data on Pitolisant for Prader-Willi Syndrome
Harmony Biosciences presented safety and efficacy data from a phase 2 study evaluating pitolisant for the treatment of excessive daytime sleepiness in people with Prader-Willi syndrome at SLEEP 2023.Â
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Harmony Hits Enrollment Target Early for Phase 3 Study of Pitolisant for IH
The phase 3 registrational INTUNE study will evaluate the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia.
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Harmony to Present Phase 2 Results of Pitolisant in Prader-Willi Syndrome
Harmony Biosciences will present the results, which it says it is “especially encouraged by,” during a poster presentation at SLEEP 2023 in Indianapolis.
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Study Compares Efficacy of Wakefulness-Promoting Agents in Sleep Apnea
In a study comparing the effectiveness of wakefulness-promoting agents, researchers pinpointed which drug is likely the most effective in treating excessive daytime sleepiness for people with sleep apnea.
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OSA Patients May Discontinue Wakefulness Drugs Due to Side Effects
According to a review of 14 trials involving patients with OSA already on conventional therapy, adverse events associated with several wakefulness drugs increased the risk of discontinuation in several trials.
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Harmony Biosciences Reports Continued Momentum for PitolisantÂ
The company reported business updates for the quarter ending March 31, noting continued momentum in its commercial business for Wakix, as well as in the advancement of its clinical development programs for pitolisant for the treatment of idiopathic hypersomnia.
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Pitolisant Trial for Idiopathic Hypersomnia Ahead of Schedule
Harmony Biosciences announced an accelerated timeline for completing its phase 3 study evaluating pitolisant in adults idiopathic hypersomnia.
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Pitolisant Trialed for Obstructive Sleep Apnea in Japan
Aculys Pharma Inc has initiated a phase 3 clinical study in Japan of pitolisant in patients with OSA who have excessive daytime sleepiness.
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