A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005
Latest Information Update: 25 Feb 2025
At a glance
- Drugs Ebselen (Primary)
- Indications Meniere's disease
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms STOPMD-3
- Sponsors Sound Pharmaceuticals
Most Recent Events
- 20 Feb 2025 According to a Sound Pharmaceuticals media release, company will present data from this study at Pharmaceutical Interventions for Hearing Loss (PIHL) Satellite Symposium on Friday, Feb 21, at 1-5pm ET.
- 10 Dec 2024 According to a Sound Pharmaceuticals media release ,company announce that the pivotal Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory compound (ebselen), for the treatment of Menieres Disease (STOPMD-3), achieved its co-primary endpoints for efficacy involving improvements in hearing loss and speech discrimination.
- 10 Dec 2024 According to a Sound Pharmaceuticals media release, Primary endpoint (Change in low frequency hearing thresholds measured by pure tone audiometry) has been met.