Posted by Michael Wonder on 01 Dec 2025
Sound Pharmaceuticals receives FDA breakthrough therapy designation for SPI-1005 to treat Meniere’s disease
1 December 2025 - Sound Pharmaceuticals is pleased to announce that the FDA has granted its investigational new drug, SPI-1005, breakthrough therapy designation for the treatment of hearing loss in patients with Meniere’s disease.
SPI-1005 also received fast track designation for the treatment of Meniere’s disease after completing a Phase 2b in Meniere’s disease.
