Tonix Pharmaceuticals Receives approval for Tonmya™ to Treat Fibromyalgia
Saturday, August 16, 2025
Tonix Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Tonmya™ (cyclobenzaprine HCl sublingual tablets) as a treatment for fibromyalgia in adults.
Fibromyalgia affects an estimated 10 million adults in the United States, most of them women. The condition is thought to result from increased sensitivity in the central nervous system and can cause widespread pain, poor sleep, fatigue, stiffness, cognitive difficulties, and mood disturbances. Patients with fibromyalgia often face impaired quality of life and higher medical costs compared with the general population.
Tonmya, previously studied under the name TNX-102 SL, is a patented sublingual version of cyclobenzaprine hydrochloride. The formulation allows faster absorption and reduces the production of a long-lasting metabolite linked to potential side effects. Tonix holds multiple patents that provide market exclusivity in the United States until at least 2034, with pending applications that could extend protection until 2044.
This marks the first new FDA-approved therapy for the condition in more than 15 years.
Tonmya is a once-daily, non-opioid medicine designed to be taken at bedtime. Its sublingual formulation allows rapid absorption into the bloodstream, aiming to address fibromyalgia symptoms such as chronic pain, fatigue, and sleep disturbance.
The approval was supported by results from two Phase 3 clinical trials involving almost 1,000 patients. In both studies, Tonmya significantly reduced daily pain scores compared with placebo after 14 weeks, which was the main goal of the trials. More patients receiving Tonmya also experienced a clinically meaningful improvement in pain compared with those on placebo.
In total, more than 1,400 patients have been studied across three Phase 3 trials. Tonmya was generally well tolerated, with the most common side effects including mouth numbness, discomfort, altered taste, drowsiness, tingling sensations in the mouth, mouth pain, fatigue, dry mouth, and mouth ulcers.
Tonmya is expected to be available for adult patients with fibromyalgia in the US from the fourth quarter of this year.
Source: tonixpharma.com
