Topline Findings
- First FDA-Approved Fibromyalgia Therapy in 15 Years: Tonmya (cyclobenzaprine HCl sublingual tablets) provides adults with a novel, non-opioid treatment option for chronic fibromyalgia pain.
- Clinically Proven Pain Reduction: Phase III RELIEF and RESILIENT trials showed significant decreases in daily pain scores and ≥30% clinically meaningful improvement compared to placebo at 14 weeks.
- Improved Sleep and Daily Function: Tonmya’s bedtime sublingual formulation addresses nonrestorative sleep, fatigue, and functional limitations, offering a comprehensive approach to fibromyalgia symptom management.
The FDA has approved Tonix Pharmaceuticals’ Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, marking the first new therapy approved for this condition in over 15 years. The approval was based on results from the Phase III RELIEF (NCT04172831) and RESILIENT (NCT05273749) trials, which demonstrated that Tonmya significantly reduced daily pain scores compared to placebo at week 14.1
What makes Tonmya a Breakthrough Option for Fibromyalgia Patients?
“The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the US suffering from the debilitating pain this condition causes,” said Seth Lederman, MD, CEO, Tonix Pharmaceuticals, in a press release. “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.”
RELIEF and RESILIENT Trial Design and Methodology
- The randomized, parallel-group, double-blind, placebo-controlled RELIEF and RESILIENT trials evaluated the efficacy and safety of Tonmya in 503 and 457 patients with fibromyalgia, respectively.
- In both trials, the initial two weeks served as a run-in period during which participants received either Tonmya 2.8 mg or placebo.
- For the remaining 12 weeks, the dose was increased to 5.6 mg or two placebo tablets.
- The primary endpoint for both trials was the change from baseline to week 14 in daily diary pain intensity scores.
- Key secondary endpoints included the number of patients with a Patient’s Global Impression of Change (PGIC) rating of "Very Much Improved" or "Much Improved," change from baseline to week 14 in the Fibromyalgia Impact Questionnaire – Revised (FIQR) symptoms domain score, and change from baseline to week 14 in the FIQR function domain score.2,3
Efficacy Results
- Results from the RESILIENT trial showed that treatment with Tonmya led to significantly greater reductions in pain compared to placebo (mean [SE] −1.8 [0.12] vs −1.2 [0.12], P < .001).4
- Additionally, ≥30% of patients taking Tonmya experienced a clinically meaningful improvement after three months compared to patients in the placebo group.1
Safety Profile
The most common adverse events associated with Tonmya included oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.1,4
“The chronic pain of fibromyalgia is debilitating to every aspect of a person’s life, including causing sleep disturbance and fatigue, all of which can negatively impact someone’s ability to carry out their daily activities,” said Sharon Waldrop, founder, Fibromyalgia Association, in the press release. “For over 15 years, this community has been underserved and waiting for new treatment options. This approval is a promising step forward and brings renewed hope to millions.”
Fibromyalgia Prevalence
- An estimated 160 million people are currently living with fibromyalgia globally.
- This includes four million people in the United States, three million people in the United Kingdom, and one million people in Australia.
- Most patients receive a diagnosis between the ages of 40 to 60 years.5
Expert Perspective
“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,” said Philip Mease, MD, director, rheumatology research, Providence Swedish Medical Center, clinical professor, University of Washington School of Medicine, in the press release. “Tonmya is a novel treatment approach that targets nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”
References
- Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia. GlobeNewswire. August 15, 2025. Accessed August 18, 2025. https://www.globenewswire.com/news-release/2025/08/15/3134450/28908/en/Tonix-Pharmaceuticals-Announces-FDA-Approval-of-Tonmya-cyclobenzaprine-HCl-sublingual-tablets-for-the-Treatment-of-Fibromyalgia.html
- A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia (RELIEF). Clinicaltrials.gov. Accessed August 18, 2025. https://clinicaltrials.gov/study/NCT04172831?term=NCT04172831&rank=1
- A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia (RESILIENT). Clinicaltrials.gov. Accessed August 18, 2025. https://clinicaltrials.gov/study/NCT05273749?term=NCT05273749&rank=1
- Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine. Oxford Academic. Accessed August 18, 2025. https://academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaf089/8193722?login=false
- Fibromyalgia by Numbers: Key Statistics You Need to Know. MoreGoodDays. Accessed August 18, 2025. https://www.moregooddays.com/post/fibromyalgia-by-numbers-key-statistics-you-need-to-know
