The short version
- In a placebo-controlled trial of 221 people with Ménière’s disease, about a third of those on the oral drug SPI-1005 gained at least 10 dB of hearing, against about one in ten on placebo.
- The new figures come from an analysis the company ran after the trial ended, and we found no peer-reviewed paper reporting the trial.
- The drug has FDA Breakthrough Therapy status for hearing loss in Ménière’s disease, which speeds review but is not approval.
Sound Pharmaceuticals, a Seattle company, presented a new analysis of its Phase 3 trial of SPI-1005, an oral anti-inflammatory built on a compound called ebselen, at the American Academy of Otolaryngology–Head and Neck Surgery annual meeting in Los Angeles. The trial randomized 221 adults with Ménière’s to the drug or a placebo twice a day for 28 days. At day 84, 33.7% of those on the drug had gained an average of at least 10 dB across four low and middle frequencies, against 9.3% on placebo. On a words-in-noise test, 42.1% improved against 27.1%.
The company reported in 2024 that the double-blind trial met both of its main goals. These new cuts of the data were chosen afterwards, which makes them weaker evidence. Every number here comes from the company, as reported by the trade site Hearing Health & Technology Matters. Neither report mentions a peer-reviewed paper, and we did not find one. The company also says the findings support testing the drug for sudden hearing loss. The trade report stresses that this analysis does not show that.
SPI-1005 holds FDA Fast Track and Breakthrough Therapy designations for Ménière’s-related hearing loss. It is not approved.
