Tonix Presents Clinical Data On Tonmya For Treatment Of Fibromyalgia At PAINWEEK Conference 2025; Phase 3 Data Support Q4 Launch Following PAINWEEK Showcase

Author: Benzinga Newsdesk | September 08, 2025 07:04am

Tonmya was approved by FDA on August 15, 2025 for the treatment of fibromyalgia and is the first new FDA approved treatment for fibromyalgia in over 15 years

Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo

Tonmya showed consistent improvements across core fibromyalgia symptoms, including widespread pain, sleep disturbance and fatigue

Tonmya was well tolerated, supporting its potential as a long-term treatment option for fibromyalgia

Tonmya is expected to be commercially available in the fourth quarter

CHATHAM, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, presented four posters at the PAINWEEK conference 2025, held September 2-5, 2025, in Las Vegas, Nevada entitled:

• "TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia"
• "Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials"
• "Steady-state Pharmacokinetic Properties of a Sublingual Formulation of Cyclobenzaprine (CBP) HCl (TNX-102 SL): Comparison to Simulations of Oral immediate-release CBP"
• "Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia"

Posted In: TNXP