EXCITING NEWS FOR THE AHC COMMUNITY! 🚨
Aspartes Pharmaceuticals has announced that the FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to ASP-001, an investigational formulation of flunarizine being developed specifically for Alternating Hemiplegia of Childhood (AHC).
💊 ASP-001 is an orally disintegrating tablet designed to dissolve in the mouth and is being developed in pediatric-friendly 2 mg and 5 mg doses.
This does not mean flunarizine is FDA-approved or commercially available in the U.S. yet. But it does mean that a medication long used by many AHC families internationally is now moving through a formal U.S. drug-development pathway for AHC.
For a community with no FDA-approved treatment specifically for AHC, this is an important and encouraging milestone. 💙
We are excited to follow ASP-001’s progress and what it could mean for AHC families in the future.