New Clinical Data on Tonmya for the Treatment of Fibromyalgia

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Tonix Pharmaceuticals presented 4 posters on Tonmya for the treatment of fibromyalgia at the PAINWEEK conference 2025, held September 2-5, 2025, in Las Vegas, Nevada.^1,2 Tonmya, which was investigated under the name TNX-102 SL, is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.

On August 15, 2025, the US Food and Drug Administration (FDA) approved Tonmya for the treatment of fibromyalgia, making it the first new FDA approved treatment for fibromyalgia in over 15 years.³

“Fibromyalgia is a chronic and debilitating condition marked by widespread pain, poor sleep, and fatigue and cognitive dysfunction,” said Seth Lederman, MD, the chief executive officer of Tonix Pharmaceuticals. “The data presented at PAINWEEK show that Tonmya significantly improved pain with a favorable tolerability profile, offering patients and physicians a new, non-opioid treatment option. Now that Tonmya has been approved by FDA, we believe we are well-positioned to execute the launch and remain on track to deliver this drug to patients next quarter.”

The posters included data from 2 pivotal phase 3 trials: RELIEF, a 14-week randomized, double-blind, placebo-controlled study of TNX-102 SL 5.6 mg; and RESILIENT, a confirmatory trial evaluating efficacy and safety. The RELIEF and RESILIENT studies were 2-arm trials that enrolled 503 and 457 adult participants with fibromyalgia across 40 and 33 United States sites, respectively. In both trials, the first 2 weeks of treatment were a run-in period in which participants started on Tonmya 2.8 mg (1 tablet) or placebo. Then, all participants increased their dose to Tonmya 5.6 mg (2 x 2.8 mg tablets) or 2 placebo tablets for the remaining 12 weeks. The primary endpoint across both trials was the daily diary pain intensity score change (Tonmya 5.6 mg vs placebo) from baseline to week 14 (using the weekly averages of the daily numerical rating scale scores).

Tonmya significantly reduced fibromyalgia pain and demonstrated a favorable tolerability profile across both these studies. As to mechanism of action, Tonmya pharmacologically targets nonrestorative sleep through antagonism of receptors that regulate sleep architecture, and thus engages a central mechanism believed to drive the persistence of fibromyalgia symptoms. Once available, Tonmya could help support earlier diagnosis and intervention, and ultimately improve patient outcomes.

There was also a replicate phase 3 trial, RALLY, to RELIEF and RESILIENT that demonstrated greater but nonsignificant treatment effect with Tonmya compared with placebo and demonstrated consistent safety. The results of this trial may not be generalizable due to the presence of factors outside the conduct of the study.

Tonmya is expected to be commercially available in the fourth quarter.

References

1. Tonix Pharmaceuticals presents clinical data on Tonmya™ for the treatment of fibromyalgia at PAINWEEK 2025. News release. September 8, 2025. Accessed September 9, 2025. https://ir.tonixpharma.com/news-events/press-releases/detail/1587/tonix-pharmaceuticals-presents-clinical-data-on-tonmya

2. Dennis M. Alkermes, Takeda detail results underpinning orexin drugs for narcolepsy. First Word Pharma. September 8, 2025. Accessed September 9, 2025. https://firstwordpharma.com/story/5995609

3. Walters J. FDA approves Tonmya, first fibromyalgia medication in 15 years. Psychiatric Times. August 15, 2025. https://www.psychiatrictimes.com/view/fda-approves-tonmya-first-fibromyalgia-medication-in-15-years