SEATTLE, WASHINGTON — Sound Pharmaceuticals announced that it has completed enrollment in its second Phase 3 open-label study of SPI-1005 for the treatment of Ménière’s disease (MD). SPI-1005, an investigational oral anti-inflammatory drug, received FDA Breakthrough Therapy Designation in late 2025 ....
No actionable change — enrollment completion is a trial milestone only; results are not yet available and the drug remains investigational.
If Phase 3 results are positive, SPI-1005 could become the first FDA-approved oral pharmacotherapy specifically targeting Ménière's disease, potentially shifting treatment paradigms for audiologists and otolaryngologists.
- 01Sound Pharmaceuticals completed enrollment in its second Phase 3 open-label trial of SPI-1005 for Ménière's disease.
- 02SPI-1005 is an investigational oral anti-inflammatory drug — no approved equivalent currently exists for this indication.
- 03The drug holds FDA Breakthrough Therapy Designation, which may accelerate regulatory review if results are favorable.
- 04This is an open-label study design, meaning both participants and investigators know who is receiving the drug.
- 05No efficacy or safety results have been published; enrollment completion does not confirm clinical benefit.
SPI-1005 has received FDA Breakthrough Therapy Designation for Ménière's disease.
press releasesupportedSPI-1005 is an oral anti-inflammatory drug effective for treating Ménière's disease.
press releaseunclear