CHATHAM -
In the poster presentation titled, Targeting Non-Restorative Sleep in Fibromyalgia with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) Significantly Improves Pain in RESILIENT, a Confirmatory Phase 3 Randomized Clinical Trial , Tonyma met the pre-specified primary endpoint in the Phase 3 RESILIENT trial, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia while also demonstrating broad syndromal improvement. Tonmya demonstrated statistically significant improvement in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. Tonmya was well tolerated with an adverse event (AE) profile comparable to prior studies and no new safety signals observed.
In pre-specified exploratory analyses, Tonmya treatment also improved depressive symptoms measured by the Beck Depression Inventory and improved female sexual function by the Changes in Sexual Function Questionnaire in the RESILIENT trial.
People suffering with fibromyalgia tend to struggle with daily activities, have impaired quality of life and are frequently disabled , said
Tonix remains on track to submit an NDA to the
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix s development portfolio is focused on central nervous system (CNS) disorders. Tonix s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and is in Phase 2 development supported by a grant from the National institute of Drug Abuse. Tonix s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
Tonix s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Tonmya is conditionally accepted by the
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as anticipate, believe, forecast, estimate, expect, and intend, among others. These forward-looking statements are based on Tonix s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended
Contact:
Email: investor.relations@tonixpharma.com
Tel: (862) 904-8182
Email: peter.vozzo@westwicke.com
Tel: (443) 213-0505
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