TONMYA Debuts as First FDA-Approved Fibromyalgia Treatment in Over 15 Years: Key Data and Safety Insights
TONMYA Offers New Hope to 10 Million Americans With Fibromyalgia
Tonix Pharmaceuticals (NASDAQ: TNXP) has announced the U.S. commercial availability of TONMYA (cyclobenzaprine HCl sublingual tablets), marking the first new FDA-approved fibromyalgia therapy in more than 15 years. TONMYA stands out as a once-daily, non-opioid, bedtime analgesic designed to reduce widespread pain in adults living with fibromyalgia—an often-debilitating disorder affecting an estimated 10 million Americans, most of whom are women.
Approved on August 15, 2025, TONMYA enters a therapeutic landscape that has seen little innovation, addressing unmet needs with a novel formulation and robust supporting evidence from Phase 3 trials.
Phase 3 Trials Confirm Pain Reduction and Improved Quality of Life
The FDA’s approval of TONMYA was grounded in efficacy data from two double-blind, randomized, placebo-controlled Phase 3 trials (RELIEF and RESILIENT) and safety results across three late-stage studies involving over 1,400 patients.
Key trial results revealed:
| Trial | Participants | Primary Endpoint | Outcome |
|---|---|---|---|
| RELIEF | 503 | Pain reduction at 14 weeks | Significantly reduced daily pain scores vs. placebo |
| RESILIENT | 457 | Pain reduction at 14 weeks | Significantly reduced daily pain scores vs. placebo |
Across both trials, a greater percentage of TONMYA-treated participants reported a clinically meaningful (=30%) pain improvement at three months versus those on placebo. Secondary endpoints included better patient-reported global change, improved sleep disturbance and reduced fatigue, underscoring the therapy’s impact on daily functioning and well-being.
Safety Profile Remains a Focus: Key Adverse Reactions and Contraindications
TONMYA demonstrated general tolerability throughout its clinical development. The most common side effects (reported in =2% of TONMYA-treated patients at higher rates than placebo) included:
- Oral hypoesthesia (mouth numbness)
- Oral discomfort
- Abnormal taste
- Somnolence (drowsiness)
- Oral paresthesia (tingling/burning sensation)
- Fatigue and dry mouth
- Aphthous ulcer (canker sore)
Important contraindications involve known hypersensitivity to cyclobenzaprine, concurrent use with MAO inhibitors, recovery from myocardial infarction, specific cardiac issues, and hyperthyroidism. Prescribers should review the full safety labeling for drug interactions and precautions, including the risk of serotonin syndrome when used with other serotonergic agents.
Market Exclusivity Through 2034 and Ongoing Innovation
TONMYA is protected by a series of U.S. patents, expected to provide exclusivity until at least 2034, with potential extensions to 2044 through pending applications. Its sublingual tablet formulation uses proprietary technologies designed to enhance absorption and minimize the production of long-acting metabolites.
| Patent Number | Year Issued | Estimated Exclusivity |
|---|---|---|
| 9636408 | 2017 | 2034 |
| 9956188 | 2018 | 2034 |
| 10117936 | 2018 | 2034 |
| 10357465 | 2019 | 2034 |
| 10736859 | 2020 | 2034 |
Takeaway: TONMYA's Entry Signals Progress in Fibromyalgia Care
For patients, families, and care teams impacted by fibromyalgia, TONMYA’s arrival represents a long-awaited option in the chronic pain management arsenal. With a proven reduction in pain and meaningful gains in sleep and function, its adoption in clinical practice will be watched closely—especially as the market evaluates long-term real-world effectiveness and accessibility for the millions seeking relief.
As always, patients and providers should consult full prescribing information and weigh benefits against potential risks before starting treatment. Further clinical experience will help clarify where TONMYA fits among available therapies and how it can be optimized for individual patient needs.
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