Tonix Pharmaceuticals gains FDA approval for Tonmya™ in the treatment of fibromyalgia
Saturday, August 16, 2025
Tonix Pharmaceuticals Holding Corp. has announced that the U.S. Food and Drug Administration (FDA) has approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime therapy designed for rapid absorption through a sublingual formulation. It is the first new FDA-approved treatment for fibromyalgia in more than 15 years.
The approval is supported by results from two double-blind, randomised, placebo-controlled Phase 3 trials involving nearly 1,000 patients. In both studies, Tonmya significantly reduced daily pain scores at 14 weeks compared with placebo, which was the primary endpoint. A greater proportion of patients receiving Tonmya also achieved a clinically meaningful improvement in pain of at least 30% after three months.
Across three Phase 3 trials involving over 1,400 patients, Tonmya was generally well tolerated. The most common side effects (occurring in at least 2% of patients and more frequently than with placebo) included oral numbness, discomfort or tingling, altered taste, drowsiness, oral pain, fatigue, dry mouth, and mouth ulcers.
Tonmya has been developed to target non-restorative sleep, a feature closely linked with fibromyalgia, with the aim of improving pain as well as other core symptoms such as fatigue and sleep disturbance.
Tonmya is expected to become available to adults in the U.S. with fibromyalgia in the fourth quarter of this year.
Source: globenewswire.com
