TNX-102 SL Data Supports Recent Fibromyalgia Approval

New data on TNX-102 SL continue to demonstrate its benefit in reducing pain in people with fibromyalgia compared to placebo.1,2,3

The new findings are from 2 pivotal phase 3 trials, RESILIENT and RELIEF, data from which were presented at the PAINWEEK conference 2025, held September 2-5, 2025, in Las Vegas, Nevada. The trials further support TNX-102 SL’s use following its approval by the United States Food and Drug Administration (FDA) in August 2025 under the name Tonyma, marking the first new drug for fibromyalgia added to the market in over 15 years.4

“Fibromyalgia is a chronic and debilitating condition marked by widespread pain, poor sleep, and fatigue and cognitive dysfunction,” Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals, said in a statement.5 “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 findings demonstrated that TNX-102 SL demonstrated significant improvement in the primary endpoint of change in weekly pain scores at Week 14 compared to placebo (P <.0001) in the RESILIENT trial. At Week 14, the least squares mean (LSM) weekly average of daily pain scores was 4.1 (95% CI, 3.8-4.3) for TNX102 SL compared to 4.7 (95% CI, 4.5-5.0) for placebo. LSM changes from baseline were -1.8 (95% CI, -2.0 to -1.6) for TNX-102 SL compared with -1.2 (95% CI, -1.4 to -0.9) for placebo.1

Lederman and colleagues also found that all 6 key secondary endpoints were statistically significant (all P ≤.001). The effect size for the primary endpoint was 0.38, and all 5 continuous key secondary endpoints’ effect sizes ranged from 0.30 – 0.50. All items, including affective and cognitive items on Fibromyalgia Impact Questionnaire – Revised (FIQR), showed similar improvement by mixed-model repeated-measures (MMRM) analysis. Both TNX-102 SL and placebo groups had similar correlations between sleep and pain improvement from baseline to Week 14.1

“TNX-102 SL reduced the pain primary endpoint in fibromyalgia and appears to lead to syndromal improvement. Results of TNX-102 SL therapy in RESILIENT support the hypothesis that targeting nonrestorative sleep in FM has the potential for syndromal improvement, and it is generally well tolerate,” Lederman and colleagues wrote.1

Stratifying by sex, female participants receiving TNX-102 SL had larger mean improvements from baseline in total Changes in Sexual Functioning Questionnaire (CSFQ)-14 score at Week 14 compared to those receiving placebo, with nominally significant improvements on desire/frequency (P = .010), orgasm/completion (P = .007), and total sexual function scores (P = .010) were all nominally significant. Sexual function could not be meaningfully assessed in male participants due to the small study population.1

TX-102 SL was well-tolerated, with treatment emergent adverse events (TEAE)-related discontinuations occurring in 6.1% and 3.6% of subjects in the TNX-102 SL and placebo groups, respectively. In general, the rate of systemic TEAEs was low, with only fatigue at a rate ≥3%. There were no clinically meaningful differences in change from baseline in systolic or diastolic blood pressure or weight between the TNX-102 SL and placebo groups at Week 14.

“Together, these findings are consistent with the concept that disturbed sleep in FM is an obstacle to recovery and pharmacological targeting of nonrestorative sleep may facilitate recovery,” Lederman and colleagues wrote.1

References

1. Lederman S, Kelley M, Engels JM, Sullivan GM. Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia. Presented at: PAINWEEK; September 2-5, 2025; Las Vegas. Poster #46.

2. Sullivan GM, Gould E, Kelley M, Engels JM, Lederman S. TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia. Presented at: PAINWEEK; September 2-5, 2025; Las Vegas. Poster #37.

3. Lederman S, Kelley M, Engels JM, Gould E, Sullivan GM. Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials. Presented at: PAINWEEK; September 2-5, 2025; Las Vegas. Poster #36.

4. Johnson V. FDA Approves TNX-102 SL, First New Fibromyalgia Therapy in 15 Years. Article. HCPLive. August 15, 2025. https://www.hcplive.com/view/fda-approves-tnx-102-sl-first-new-fibromyalgia-therapy-in-15-years

5. Tonix Pharmaceuticals Presents Clinical Data on Tonmya™ for the Treatment of Fibromyalgia at PAINWEEK 2025. News release. Tonix Pharmaceuticals. September 8, 2025. https://finance.yahoo.com/news/tonix-pharmaceuticals-presents-clinical-data-110000130.html