FDA Approves TNX-102 SL, First New Fibromyalgia Therapy in 15 Years

On August 15, 2025, the US Food and Drug Administration (FDA) approved Tonix Pharmaceuticals' TNX-102 SL, under the name Tonmya, for treating adults with fibromyalgia, the first new drug for the indication in more than 15 years.1

“For many years, rheumatologists like myself and other healthcare professionals have had to manage fibromyalgia with limited options that do not adequately meet treatment needs for the majority of patients,” Philip Mease, MD, director of Rheumatology Research at the Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, said in a statement.1 “Tonmya is a novel treatment approach that targets nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”

TNX-102 SL is a sublingual formulation of cyclobenzaprine and is also the first member of a new class of non-opioid analgesic drugs for fibromyalgia. Tonix originally announced the FDA's acceptance of its new drug application for the medication in December 2024.2

The FDA approval is based on data from the phase 3 RESILIENT study. The most recent data from RESILIENT was presented at the European Alliance of Associations for Rheumatology (EULAR) Congress 2025 in Barcelona, Spain, taking place June 11-14, 2025. Data were from 457 patients with fibromyalgia to TNX-102 SL 5.6 mg administered before bedtime (n = 231) or placebo (n = 226). Participants were mostly female (n = 436; 95.4%) and were mostly White/Caucasian (n = 386; 84.5%). They had a mean duration of 9.2 years of fibromyalgia disease (standard deviation [SD], 9.0) and a mean 5.9 (SD, 1.1) numeric rating scale (NRS) pain score at baseline.3

Investigators found that TNX-102 SL demonstrated a highly statistically significant improvement in the primary endpoint of statistically significantly reducing daily NRS pain scores compared with placebo starting at week 1 and continuing until Week 14 (P <.0001), with an effect size of 0.38.3

“I know firsthand how the chronic pain of fibromyalgia significantly disrupts my patients’ lives,” Andrea L. Chadwick, MD, MSc, of the Department of Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Health System, added.1 “Treatments that are processed through the liver can result in metabolites that could affect a medicine’s efficacy and safety over time. Tonmya is administered sublingually which is designed to reduce pain quickly and durably with a tolerable safety profile.”

Furthermore, the key secondary endpoints of Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance, PROMIS fatigue, and diary sleep quality ratings were all found to be statistically significant (all P <.001) compared to placebo, with effect sizes ranging from 0.32–0.50.3

In terms of safety, 81.0% of patients on TNX-102 SL and 79.2% on placebo completed the study, with treatment-emergent adverse events (AEs) leading to discontinuation in 6.1% and 3.6%, respectively. Serious AEs occurred in 2 patients (0.9%) on TNX-102 SL and 3 patients on placebo had serious adverse events, 1 event of acute pancreatitis in the TNX-102 SL group was considered possibly related to treatment. Investigators did not observe any safety signals by vital signs, weight, clinical labs, or physical exams or on C-SSRS or BDI-II.3

“The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this condition causes,” Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals, added.1 “At Tonix, we recognized the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition (COPC), that has gone without innovation for many years. We are hopeful that effectively treating pain with Tonmya could help improve the lives of people with this chronic syndrome.”

REFERENCES

1. Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia. News release. Tonix Pharmaceuticals. August 15, 2025. https://ir.tonixpharma.com/news-events/press-releases/detail/1585/tonix-pharmaceuticals-announces-fda-approval-of

2. Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia. Globe Newswire. December 17, 2024. https://www.globenewswire.com/news-release/2024/12/17/2998199/28908/en/Tonix-Pharmaceuticals-Announces-FDA-Acceptance-of-the-New-Drug-Application-NDA-for-TNX-102-SL-for-Fibromyalgia.html. Accessed December 17, 2024.

3. Iglehart III I, Sullivan G, Lederman S. Advancing Fibromyalgia Treatment: Transmucosal Sublingual Cyclobenzaprine (Tnx-102 SL) Targets Nonrestorative Sleep and Provides Sustained Pain Reduction.