Dec. 01, 2025
Sound Pharmaceuticals Receives FDA Breakthrough Therapy Designation for SPI-1005 in Meniere’s Disease
SEATTLE, WASHINGTON — Sound Pharmaceuticals (SPI) announced that the U.S. Food and Drug Administration (FDA) has granted its investigational drug, SPI-1005, Breakthrough Therapy Designation (BTD) for the treatment of hearing loss associated with Meniere’s disease (MD). MD is a complex inner ear disorder involving low-to-mid frequency hearing loss, tinnitus, vertigo, and dizziness. This marks the first BTD granted for a












