Meniere’s Disease Emerging drugs and Key Players | DelveInsight

August 14 15:11 2020
Meniere's Disease Emerging drugs and Key Players | DelveInsight

DelveInsight Business Research LLP
Meniere’s Disease Pipeline Insight, 2020″ report by DelveInsight outlays comprehensive insights of present clinical development scenario and growth prospects across the Meniere’s Disease (MD) market. A detailed picture of the Meniere’s Disease (MD) pipeline landscape is provided, which includes the disease overview and Meniere’s Disease (MD) treatment guidelines.

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.

 

UNMET NEEDS 

  • 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).

 

Meniere’s disease Emerging Drugs Analysis

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.

 

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Table of contents

1. Report Introduction

2. Meniere’s Disease (MD) 

2.1. Overview

2.2. History 

2.3. Meniere’s Disease (MD) Symptoms

2.4. Causes

2.5.Pathophysiology

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

4.1.1.1. Assessment Summary

4.1.2. Meniere’s Disease (MD) Collaboration Deals

4.1.2.1. Company-Company Collaborations (Licensing / Partnering) Analysis

4.1.2.2. Company-University Collaborations (Licensing / Partnering) Analysis

4.1.2.3. 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)

5.1.2.1. Assessment by Stage and Product Type

5.1.3. Assessment by Route of Administration

5.1.3.1. Assessment by Stage and Route of Administration

5.1.4. Assessment by Molecule Type

5.1.4.1. Assessment by Stage and Molecule Type

5.1.5. Assessment by MOA

5.1.5.1. Assessment by Stage and MOA

5.1.6. Assessment by Target

5.1.6.1. 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

13.1.1.1. Product Overview

13.1.1.2. Mechanism of action

13.1.2. Research and Development

13.1.2.1. Clinical Studies

13.1.3. Product Development Activities

13.1.3.1. Collaboration

13.1.3.2. Agreements

13.1.3.3. Acquisition 

13.1.3.4. Patent Detail

13.1.4. Tabulated Product Summary

13.1.4.1. 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  

20. Appendix

21. Report Methodology

21.1. Secondary Research

21.2. Expert Panel Validation 

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