11 Sep FDA Approves Tonmya: First-in-Class, Non-Opioid Analgesic for Fibromyalgia
Dr. Jain
MedicalResearch.com Interview with:
Rakesh Jain, MD, MPH
Clinical Professor at the Department of Psychiatry
Texas Tech University School of Medicine- Permian Basin
Midland, Texas
MedicalResearch.com: Would you briefly explain the condition of fibromyalgia? Whom does it primarily affect and what are the symptoms?
Response: Fibromyalgia is the prototypical example of a type of pain called nociplastic pain, or pain that comes from altered pain processing in the central nervous system. It is mainly characterized by widespread pain, non-restorative sleep, fatigue and cognitive impairment (brain fog). Over 10 million adults in the United States are affected by this disease, most of whom are women.
MedicalResearch.com: What are the main findings of the RELIEF and RESILIENT studies?
Response: RELIEF and RESILIENT demonstrated that Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks. Additionally, a greater percentage of study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain, as well as a higher threshold (≥50%) of pain reduction compared to placebo at the 3-month mark. RESILIENT was recently published.
MedicalResearch.com: How is TONMYA taken? What are the possible side effects? Are there likely to be insurance hurdles to coverage?
Response: Tonmya is administered sublingually (under the tongue) once daily at bedtime. The most common adverse events (incidence ≥2% and at a higher incidence in Tonmya-treated patients compared to placebo-treated patients) included oral hypoesthesia (numbness in the mouth), oral discomfort, abnormal product taste, somnolence (drowsiness), oral paresthesia (tingling, pricking or burning in the mouth), oral pain, fatigue, dry mouth, and aphthous ulcer (canker sore). Tonmya was generally well tolerated with the majority of adverse events related to the tongue or mouth at the administration site.
Payer coverage for Tonmya is still being determined. In the meantime, some health plans may offer initial coverage for eligible patients through their Medical Exception or other similar process. Following a formal coverage policy, certain patients may be able to access TONMYA through a Prior Authorization or other similar process. As physicians, we should work with our patients and their individual healthcare plans to find the best coverage options for them.
MedicalResearch.com: What else should readers take away from your report? (i.e. are there other conditions TONMYA may be useful for?)
Response: Tonmya is the only cyclobenzaprine product approved for Tonmya. It is a first-in-class, non-opioid analgesic for fibromyalgia that is designed to be taken once a day at bedtime and its unique sublingual formulation is designed for rapid absorption into the bloodstream.
Tonmya is also being studied in a Phase 2 trial for acute stress disorder.
Any disclosures? N/A
Citation: Press Release: Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia 8/15/2025
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Last Updated on September 11, 2025 by Marie Benz MD FAAD