What is the new drug for Ménière's? Investigating SPI-1005 and other promising therapies

October 6, 2025 •

4 min read

Over 600,000 individuals in the U.S. are affected by Ménière's disease, yet there are currently no FDA-approved medications specifically for this condition. The investigational oral drug SPI-1005, containing the compound ebselen, is a frontrunner in late-stage clinical trials, offering renewed hope for patients suffering from fluctuating hearing loss and episodic vertigo.

Quick Summary

Examines the investigational drug SPI-1005 (ebselen) for Ménière's disease, covering its anti-inflammatory mechanism and positive Phase 3 trial results showing improvements in hearing and speech discrimination. Also reviews the current treatment landscape and other potential therapies.

Key Points

SPI-1005 is a leading candidate: The investigational oral drug SPI-1005, containing $ebselen$, is the most advanced new medication being developed for Ménière's disease.
No FDA-approved drug currently exists: As of late 2024, there are no specific medications approved by the U.S. FDA to treat Ménière's disease, highlighting the critical need for new therapies.
Positive Phase 3 trial results: The SPI-1005 Phase 3 trial met its primary endpoints, showing significant improvements in hearing loss and speech discrimination over placebo.
Ebselen's mechanism is anti-inflammatory: The active compound, $ebselen$, works by mimicking the antioxidant enzyme glutathione peroxidase ($GPx$) to reduce inner ear inflammation and oxidative stress.
Current treatments are not FDA-approved for MD: Standard management options like diuretics and betahistine are not FDA-approved for Ménière's, and betahistine's US approval was withdrawn decades ago due to lack of demonstrated efficacy.

The Unmet Need for Effective Ménière's Treatment

Ménière's disease is a complex and challenging inner ear disorder characterized by a classic set of symptoms, which can vary widely in severity and frequency among patients. The hallmark signs include:

Episodic vertigo: a sudden, overwhelming sensation of spinning.
Fluctuating sensorineural hearing loss: hearing loss that comes and goes, especially in the low frequencies.
Tinnitus: a persistent ringing, buzzing, or hissing sound in the ear.
Aural fullness: a feeling of pressure or congestion in the affected ear.

For decades, treatment has primarily focused on managing symptoms rather than addressing the underlying disease mechanism, which remains unknown. Existing options often include lifestyle modifications like a low-salt diet, vestibular suppressants for acute attacks, and diuretics to help reduce inner ear fluid pressure. However, as of late 2024, the U.S. Food and Drug Administration (FDA) has not approved a specific medication to treat the condition. This represents a significant gap in care for the many people whose lives are disrupted by the unpredictable nature of Ménière's disease.

Introducing Investigational Drug: SPI-1005 (Ebselen)

SPI-1005 is an investigational, orally administered drug that has generated considerable interest due to its unique mechanism of action and promising clinical trial data. Its active component, $ebselen$, is a small molecule that mimics and induces the activity of glutathione peroxidase (GPx), a critical antioxidant enzyme. Loss of GPx activity has been linked to sensorineural hearing loss in animal models, suggesting a potential role for oxidative stress and neuroinflammation in Ménière's pathophysiology. By acting as a GPx mimic, $ebselen$ aims to reduce these inflammatory processes in the inner ear and provide protection to sensitive auditory hair cells.

Positive Phase 3 Trial Results

The most significant advance for SPI-1005 came from the pivotal Phase 3 clinical trial, STOPMD-3. The results, announced in late 2024, were highly encouraging.

Improvement in Hearing: The trial achieved its co-primary endpoints, demonstrating significant efficacy in improving hearing loss and speech discrimination in Ménière's disease patients.
Enhanced Speech Recognition: Patients receiving SPI-1005 showed significant gains in low-frequency hearing and improved speech discrimination compared to those on a placebo.
Continued Improvement in Open-Label Extension: In the follow-up open-label extension study, participants who continued on SPI-1005 treatment saw further improvements in patient-reported outcome measures for symptoms like tinnitus, vertigo, and aural fullness.

The positive outcome of this trial represents a landmark achievement in the search for a safe and effective treatment for Ménière's-related hearing symptoms.

Comparison of Ménière's Disease Treatments


Feature	SPI-1005 (Investigational)	Betahistine	Diuretics	Intratympanic Steroids
Mechanism	Mimics glutathione peroxidase ($GPx$) to reduce inflammation and oxidative stress in the inner ear.	Histamine analog thought to improve blood flow to the inner ear, reducing fluid buildup.	Reduce overall body fluid to decrease inner ear fluid volume.	Reduce inflammation directly in the inner ear via middle ear injection.
FDA Status (US)	Under review, completed Phase 3 trials for efficacy.	FDA approval withdrawn in 1972 due to insufficient evidence of efficacy.	Approved for other conditions (e.g., hypertension), used off-label for Ménière's.	Used off-label for refractory vertigo; often recommended as a second-line therapy.
Key Symptom Targeted	Hearing loss, speech discrimination, tinnitus, vertigo.	Vertigo attacks.	Vertigo attacks.	Vertigo attacks.
Administration	Oral capsule, taken twice daily.	Oral tablets, typically taken multiple times daily (compounded in US).	Oral tablets, daily.	Injection into the middle ear by a healthcare professional.

Beyond SPI-1005: Other Therapeutic Avenues

While SPI-1005 is the most advanced investigational drug for Ménière's, research continues on other fronts:

Drug Repurposing: Studies are evaluating existing, FDA-approved drugs for new applications in Ménière's disease. For example, a trial is testing montelukast, a medication for allergic rhinitis, to see if it can alleviate Ménière's symptoms.
Electrical Stimulation: Non-invasive mastoid electrical stimulation is being explored to modulate auditory symptoms and vertigo.
Better Research Standards: The scientific community is working to establish more consistent research standards, including diagnostic criteria and biomarkers, to improve the reliability of future studies. This collaboration is crucial for making more effective and robust treatment discoveries.

The Future Outlook for Ménière's Patients

The positive Phase 3 results for SPI-1005 represent a pivotal moment in Ménière's research. If approved by regulatory bodies, SPI-1005 would be the first FDA-sanctioned oral treatment for the hearing-related aspects of the disease. This could significantly improve the quality of life for many patients who currently rely on management strategies with varying levels of effectiveness. While regulatory approval is still a necessary step, the data from the STOPMD-3 trial and the ongoing progress of other research efforts provide a beacon of hope for better, more targeted therapies in the future.

For more detailed information on the SPI-1005 clinical trial (STOPMD-3), you can visit the official entry on ClinicalTrials.gov.

Frequently Asked Questions

SPI-1005 is an investigational oral drug containing the active compound $ebselen$. It is being developed by Sound Pharmaceuticals for the treatment of Ménière's disease and other neurotologic conditions like noise-induced hearing loss and tinnitus.

No, SPI-1005 is not yet FDA-approved. It has completed its pivotal Phase 3 clinical trial, but must still go through the regulatory approval process before it can be marketed and prescribed as a new medication.

SPI-1005 works by mimicking the antioxidant enzyme glutathione peroxidase ($GPx$). This helps reduce neuroinflammation and oxidative stress in the inner ear, a process believed to contribute to Ménière's symptoms like hearing loss and vertigo.

Unlike betahistine, whose FDA approval was withdrawn due to insufficient efficacy data, SPI-1005 has demonstrated significant improvements in hearing loss and speech discrimination in a recent Phase 3 trial. SPI-1005 is also an anti-inflammatory drug, whereas betahistine is a histamine analog thought to affect blood flow.

Current management includes lifestyle changes like a low-salt diet, diuretics to reduce fluid buildup, and vestibular suppressants for vertigo attacks. Intratympanic steroid injections are also used for patients with refractory vertigo.

While the Phase 3 trial is complete, the FDA review and approval process can take time. An exact timeline for commercial availability is not yet determined, and the drug's future depends on successful regulatory review.

The Phase 3 trial showed significant improvements in hearing loss and speech discrimination. Patient-reported outcome measures also indicated improvements in vertigo, tinnitus, and aural fullness during the open-label extension.

It means the FDA has not specifically reviewed and approved these drugs for use in Ménière's disease, although they are approved for other conditions. Their use for Ménière's is 'off-label,' based on clinical practice and some research, but not robust, large-scale evidence deemed sufficient by the FDA.