Tonmya Available Commercially for Treatment of Fibromyalgia

Tonix Pharmaceuticals announced that Tonmya (cyclobenzaprine HCl) is now available by prescription in the United States.¹ The treatment was approved by the US Food and Drug Administration (FDA) in August of 2025 and is now commercially available.

"The availability of TONMYA is a momentous day for Tonix, providing the estimated 10 million people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease, widespread pain,” said Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals, in a press release.¹ “After more than 15 years without innovation for this disease, we are honored to bring this new treatment option to patients in partnership with the full fibromyalgia community including researchers, patients, and investigators. We are excited and motivated to make TONMYA accessible to as many patients as possible,” Lederman added.

The most recent phase 3 trial for this drug showed significant improvements in symptoms and functioning for patients with fibromyalgia. The trial, RESILIENT, showed significant improvement (P < .001) in daily pain intensity scores at week 14.² The study also showed improvement (P < .001) in Patient Global Impression of Change scores, Fibromyalgia Impact Questionnaire (Revised) Symptoms and Function domains, Patient Reported Outcomes Measurement Information System instruments for Sleep Disturbance and Fatigue, and daily diary sleep quality scores. Between 2 other phase 3 trials conducted for efficacy, almost 1000 patients were enrolled, with primary endpoints met for reduced daily pain scores compared with placebo. Participant data also showed a meaningful improvement in pain after 3 months compared with placebo.

Further phase 3 trials for tolerance of the medication showed it was well-tolerated. Among over 1400 patients in these trials, the most common adverse events were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer. Adverse event incidence was above 2% and higher in the treatment group than placebo group.

Andrea L. Chadwick, MD, MSc, FASA, from Anesthesiology, Pain, and Perioperative Medicine at the University of Kansas Health System, said “for years, fibromyalgia patients have struggled with limited treatment options that often fall short. The availability of TONMYA marks a meaningful advancement by targeting neurotransmitters thought to be involved in fibromyalgia.”

Tonmya is a once daily, non-opioid analgesic for treatment of fibromyalgia. The approved and available form is a sublingual tablet. Tonmya allows for quick transmucosal absorption and bypasses first-pass hepatic metabolism to reduce production of norcyclobenzaprine, an active metabolite with a longer half-life. The drug is a tertiary amine tricyclic agent which binds at 5HT2A serotonergic, alpha-1 adrenergic H1 histaminergic, and M1 muscarinic receptors.

With its FDA approval, the drug was the first approved treatment for fibromyalgia in 15 years. It is now available by prescription and for pharmacy ordering in the US.

References

1. Tonix Pharmaceuticals announces US commercial availability of Tonmya (syclobenzaprine HCl sublingual tablets) as first-in-class fibromyalgia treatment. Press release. November 17, 2025. Accessed November 17, 2025. https://ir.tonixpharma.com/news-events/press-releases/detail/1602/tonix-pharmaceuticals-announces-u-s-commercial

2. Lederman S, Arnold LM, Vaughn B, et al. Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine. Pain Med. 2025.