Meniere’s disease is one of the most common inner ear diseases characterized by episodic vertigo, sensorineural hearing loss that fluctuates during episodes, tinnitus, and ear fullness.
- There are no drugs currently approved by the FDA for Meniere’s disease treatment. Current treatments commonly used for Meniere’s disease include observance of a low-salt diet and off-label use of diuretics, oral steroids, and repeat IT injections of steroid solution. Patients who are unresponsive to treatment may resort to surgical or chemical ablation, which can cause irreversible hearing loss.
- According to the Ménière’s Society in the UK, nonsurgical measures do not control symptoms of 20% of people with Ménière’s Disease.
- The American Academy of Otolaryngology-Head and Neck Surgery says success from Meniett device is variable.
- Limited knowledge of the pathophysiology of the disease makes treatment highly challenging.
Scope of the report
- The Meniere’s Disease (MD) report provides an overview of therapeutic pipeline activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and MOA type for Meniere’s Disease (MD) across the complete product development cycle, including all clinical and nonclinical stages.
- It comprises of detailed profiles of Meniere’s Disease (MD) therapeutic products with key coverage of developmental activities, including technology, collaborations, licensing, mergers and acquisition, funding, designations and other product-related details
- Detailed Meniere’s Disease (MD) research and development progress and trial details, results wherever available, are also included in the pipeline study.
- Coverage of dormant and discontinued pipeline projects along with the reasons if available across Meniere’s Disease (MD).
Currently, Otonomy Inc. and Sound Pharmaceuticals are involved in developing therapies for MD. Launch of emerging therapies, such as OTO-104 and SP-1005 are expected to significantly impact the treatment pattern of MD in the upcoming years.
OTO-104 (Otonomy Inc.) is a sustained-exposure formulation of the steroid dexamethasone for Meniere’s disease patients that has completed one successful Phase 3 clinical trial called AVERTS-2. Furthermore, an additional Phase 3 trial to support a submission for registration is ongoing. This trial remains the same primary efficacy endpoint, daily diary vertigo scale, use of a one-month lead-in period, and primary analysis at three months after a single treatment. The company plans to enroll approximately 160 patients, with the majority expected to be recruited in Europe, where the AVERTS-2 trial was conducted.
Additional steps have been taken to manage patient expectation bias and the placebo response including refinement of site selection criteria, emphasizing recruitment of well-characterized Ménière’s patients known to the investigators, and careful management of clinical site communication with studyThe U.S. has granted OTO-104 Fast Track designationby the U.S. for Meniere’s disease treatment and other inner ear conditions.
SPI-1005 (Sound Pharmaceuticals) is an investigational drug containing ebselen, a small molecule that is a new chemical entity. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx) activity. GPx activity is critical to several cell types and tissues in the inner ear, retina, brain, lung, and kidney, and is regularly reduced during exposures to environmental insults. It is given orally and tested in several neurotologic indications, including noise-induced hearing loss and tinnitus, and two types of ototoxicity (hearing loss, tinnitus, dizziness, or vertigo) due to aminoglycoside antibiotics (such as tobramycin), and due to platinum-based chemotherapy. SPI’s clinical data from two completed multi-center, randomized, placebo-controlled studies (Phase 1b and Phase 2b clinical trials) showed that oral delivery of SPI-1005 for 21 or 28 days improved sensorineural hearing loss and tinnitus in patients affected by Meniere Diseases. These improvements in auditory function further support the use of SPI-1005 to treat sudden hearing loss, noise-induced hearing loss, and age-related loss where sensorineural hearing loss and tinnitus are prominent features.
Also, Sound Pharmaceuticals has recently announced that the FDA has allowed its pivotal Phase 3 clinical protocol for SPI-1005 in the treatment of Meniere’s disease patients (STOPMD-3). STOPMD-3 protocol will be conducted at over 16 US sites. Furthermore, the FDA has granted SPI-1005, fast track designation for Meniere’s disease treatment.
1. Report Introduction
2. Meniere’s Disease (MD)
2.3. Meniere’s Disease (MD) Symptoms
2.6. Meniere’s Disease (MD) Diagnosis
2.6.1. Diagnostic Guidelines
3. Meniere’s Disease (MD) Current Treatment Patterns
3.1. Meniere’s Disease (MD) Treatment Guidelines
4. Meniere’s Disease (MD) – DelveInsight’s Analytical Perspective
4.1. In-depth Commercial Assessment
4.1.1. Meniere’s Disease (MD) companies collaborations, Licensing, Acquisition -Deal Value Trends
188.8.131.52. Assessment Summary
4.1.2. Meniere’s Disease (MD) Collaboration Deals
184.108.40.206. Company-Company Collaborations (Licensing / Partnering) Analysis
220.127.116.11. Company-University Collaborations (Licensing / Partnering) Analysis
18.104.22.168. Meniere’s Disease (MD) Acquisition Analysis
5. Therapeutic Assessment
5.1. Clinical Assessment of Pipeline Drugs
5.1.1. Assessment by Phase of Development
5.1.2. Assessment by Product Type (Mono / Combination)
22.214.171.124. Assessment by Stage and Product Type
5.1.3. Assessment by Route of Administration
126.96.36.199. Assessment by Stage and Route of Administration
5.1.4. Assessment by Molecule Type
188.8.131.52. Assessment by Stage and Molecule Type
5.1.5. Assessment by MOA
184.108.40.206. Assessment by Stage and MOA
5.1.6. Assessment by Target
220.127.116.11. Assessment by Stage and Target
6. Meniere’s Disease (MD) Late Stage Products (Phase-III)
7. Meniere’s Disease (MD) Mid Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Meniere’s Disease (MD) Discontinued Products
13. Meniere’s Disease (MD) Product Profiles
13.1. Drug Name: Company
13.1.1. Product Description
18.104.22.168. Product Overview
22.214.171.124. Mechanism of action
13.1.2. Research and Development
126.96.36.199. Clinical Studies
13.1.3. Product Development Activities
188.8.131.52. Patent Detail
13.1.4. Tabulated Product Summary
184.108.40.206. General Description Table
Detailed information in the report?
14. Meniere’s Disease (MD) Key Companies
15. Meniere’s Disease (MD) Key Products
16. Dormant and Discontinued Products
16.1. Dormant Products
16.1.1. Reasons for being dormant
16.2. Discontinued Products
16.2.1. Reasons for the discontinuation
17. Meniere’s Disease (MD) Unmet Needs
18. Meniere’s Disease (MD) Future Perspectives
19. Meniere’s Disease (MD) Analyst Review
21. Report Methodology
21.1. Secondary Research
21.2. Expert Panel Validation