Posted by Michael Wonder on 19 Sep 2019
FDA grants fast track designation for SPI-1005 in the treatment of Meniere's disease
18 September 2019 - Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request for fast track designation involving SPI-1005 in the treatment of Meniere's disease.
SPI's clinical data from two completed multi-center, randomised, placebo-controlled studies (Phase 1b and Phase 2b clinical trials) were the basis for the designation, and showed that oral delivery of SPI-1005 for 21 or 28 days improved tinnitus and restored sensorineural hearing loss in patients affected by Meniere's disease.
