Policy & Regulation
FDA grants Fast Track Designation to Sound Pharmaceuticals' SPI-1005
19 September 2019 -

It was reported yesterday that the FDA's Division of Neurology Products has granted request for Fast Track Designation for United States-based Sound Pharmaceuticals' SPI-1005 intended for the treatment of Meniere's Disease.

The company's clinical data from two completed multi-centre, randomised, placebo-controlled studies indicated that 21 or 28 days of oral treatment improved tinnitus and restored sensorineural hearing loss in patients affected by Meniere's Disease.

Fast Track Designation enables the accelerated development of SPI-1005 involving more frequent meetings with the FDA, rolling reviews, and the potential for priority review at the filing of New Drug Application. SPI has an End-of-Phase 2 Meeting scheduled with the FDA to discuss its Phase 3 study design and additional data required for NDA filing.

Jonathan Kil, MD, Co-Founder and CEO, said, 'This is a major regulatory milestone for our most advanced clinical program to date.'