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pp-048

Oral solution

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
For narcolepsy, targeting excessive daytime sleepiness and cataplexy. Phase 1 clinical development, Small-molecule formulation Designed as an optimized, next-generation oxybate formulation with significantly reduced sodium content and a once-nightly dosing profile, aiming to improve safety and convenience compared with high-sodium, twice-nightly oxybate therapies. Route / form: Oral solution, once nightly. Differentiation: Ultra-low sodium content and once-nightly dosing aim to improve cardiovascular safety, adherence, and sleep continuity vs. currently approved oxybate products.
Manufacturer #18873

A privately-held, mid-size biopharma firm focused on developing and marketing therapies for ADHD, pain, addiction and CNS disorders. It combines proprietary drug-delivery technology with global development and licensing efforts to deliver patient-friendly medications worldwide.

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