Hope for New Treatment for Ménière’s Disease?

SPI-1005 finished Phase 3 clinical trials with positive results

In 2021, I wrote a blog about an investigational new oral drug for treating Ménière’s Disease. Known as SPI-1005, it contains ebselen, a new chemical with antioxidant and anti-inflammatory activity. At the time, participants with a definite history of Ménière’s Disease were recruited for SPI-1005 Phase 3 clinical trials. This made me feel intensely – but also cautiously – optimistic. However, it is already quite an accomplishment for a substance to advance to Phase 3 of the lengthy new-drug testing & approval process. Only about 33% of submitted compounds make it this far.

During Phase 3, the chemical is tested for efficacy and side effects in volunteers who have the condition that is meant to be treated. Also, the drug’s performance results are compared to those of an inactive placebo. In July 2024, Phase 3 of ebselen’s clinical trials were completed. In December 2024, study outcomes are said to be positive and this certainly sounds encouraging. Any improvements are good news.

Next: The FDA Review Team steps in while we wait!

At the completion of Phase 3 studies, the drug company – in this case Sound Pharmaceuticals – can file for a New Drug Application (NDA) with the FDA to market their new product. The NDA contains all the clinical results from all the trials. Once it is received and the FDA Review Team has decided that all the required information is complete, it takes 6 to 10 months for the Review Team to complete its thorough evaluation. The NDA is then either granted or denied.  

In this case, one might hope for a 6-months priority review time as Sound Pharmaceuticals was granted Fast Track Designation (FTD) for SPI-1005 in 2019.

Hope beyond Ménière’s Disease?

Have we finally entered a new era of research into neurotology – the study and treatment of conditions related to the inner-ear hearing & balance system, its nerves and brain pathways? If SPI -1005’s ebselen shows positive outcomes for hearing loss and tinnitus due to Ménière’s Disease – a specific inner ear disorder – might it also be beneficial for those with inner-ear related hearing loss and tinnitus from other causes? This reminds me of a Beach Boys title: “Wouldn’t it be Nice?” Meanwhile, SPI-1005 clinical trials into other neurotology issues continue. And so, Hope stays alive for so many of us as we close out the year on an optimistic note.