A New Treatment for Fibromyalgia?

The study concluded that TNX-102 SL led to significant daily pain reductions with a good safety and tolerability profile.

Conclusion

Cyclobenzaprine hydrochloride in sublingual tablet form (TNX-102 SL; Tonmya) is the first medication to receive FDA approval for the treatment of patients with fibromyalgia in more than 15 years. Although it was well tolerated in clinical trials, these conditions are usually more ideal than in the real world.

Cyclobenzaprine has been around for more than four decades, so it is not a new pharmacologic agent, but rather a new dose and dosage form. Now that it is FDA approved, more widespread use of evening dosing of the agent, combined with real-world evidence, will demonstrate where it fits into the armamentarium for the management and care of patients with fibromyalgia.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Goldenberg DL, Kaplan M. Fibromyalgia: Treatment in adults. In: Wallace DJ, Case SM, eds. UpToDate. Wolters Kluwer. 2025 Jul.
2. Lederman S, Arnold LM, Vaughn B, et al. Efficacy and safety of sublingual cyclobenzaprine for the treatment of fibromyalgia: Results from a randomized, double-blind, placebo-controlled trial. Arthritis Care Res (Hoboken). 2023 Nov;75(11):2359–2368.
3. Forte ML, Butler M, Andrade KE, et al. Treatments for Fibromyalgia in Adult Subgroups. Agency for Healthcare Research and Quality (U.S.); 2015 Jan.
4. Supplemental new drug application approval letter: Lyrica (pregabalin). U.S. Food & Drug Administration. 2007 Jun 21.
5. FDA approves Cymbalta for the management of fibromyalgia [news release]. Eli Lilly and Company. 2008 Jun 16.
6. New drug application approval letter: Savella (milnacipran). U.S. Food & Drug Administration. 2009 Jan 14.
7. Tonix pharmaceuticals announces FDA approval of Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia [news release]. Tonix Pharmaceuticals Holding Corp. 2025 Aug 15.  
8. TNX-102 SL. Tonix Pharmaceuticals Inc. 2025.
9. Flexeril (cyclobenzaprine): Package insert/prescribing information. Drugs.com. 2025 Mar 25.
10. Tonix Pharmaceuticals announces on-line publication of phase 3 Resilient trial results of TNX-102 SL for fibromyalgia in in the peer reviewed journal, Pain Medicine [news release]. Tonix Pharmaceuticals Inc. 2025 Jul 9.
11. A phase 3 study to evaluate the efficacy and safety of TNX-102 SL taken daily in patients with fibromyalgia (RESILIENT) [NCT05273749]. Tonix Pharmaceuticals Inc. ClinicalTrials.gov. 2025 Jan 22.
12. A study to evaluate the efficacy and safety of TNX-102 SL in patients with fibromyalgia (RELIEF) [NCT05273749]. Tonix Pharmaceuticals Inc. ClinicalTrials.gov. 2022 Aug 8.