FDA Approves Tonmya, First Fibromyalgia Medication in 15 Years

gguy/Adobe Stock

BREAKING NEWS

The US Food and Drug Administration (FDA) has approved Tonix Pharmaceuticals' Tonmya (cyclobenzaprine HCl, formerly known as TNX-102 SL), a novel treatment form for fibromyalgia.¹ The drug is now the first in a new category of non-opioid analgesics for fibromyalgia and the first new medication for this disorder in 15 years.

The FDA’s approval cited efficacy from 2 double-blind, randomized, placebo-controlled, phase 3 clinical trials of almost 1000 patients that evaluated Tonmya as treatment for fibromyalgia. Across both phase 3 trials, Tonmya significantly reduced daily pain scores compared with placebo at the primary endpoint of 14 weeks. In these trials, a greater percentage of patients taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after 3 months, as compared with placebo. Across phase 3 clinical trials with over 1,400 patients evaluated, Tonmya was generally well tolerated. The most common adverse events (incidence ≥2%) included oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals, said the approval “represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this condition causes.” He added that “at Tonix, we recognized the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition, 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.”

Tonmya is a sublingual formulation of cyclobenzaprine (CBP) designed to act centrally to reduce norcyclobenzaprine (nCBP) to improve sleep quality and thereby relieve pain.² With a sublingual administration, the medication can act faster via transmucosal absorption; this absorption avoids first-pass hepatic metabolism and reduces formation of the metabolite nCBP that occurs with oral CBP, which is associated with adverse effects. Tonmya has antagonist activities at the serotonergic, adrenergic, histaminergic, and muscarinic receptors.

Andrea Chadwick, MD, MSc, FASA, at the University of Kansas Health System weighed in on this novel administration form: “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.”

The drug currently has active indications as a daily bedtime treatment for posttraumatic stress disorder, alcohol use disorder, and agitation in Alzheimer disease. Tonmya also has been designated Fast Track approval by the FDA for agitation in Alzheimer disease.

From a phase 1 pharmacokinetic study comparing oral CBP and Tonmya, investigators found that following the first and last dose of sublingual Tonmya, exposure to CBP and nCBP was less than with oral CBP capsules.³ In both oral and sublingual administration groups, researchers found the same 9 phase I metabolites and 8 phase II metabolites in participant’s plasma. From a subsequent phase 3 RESILIENT study, Tonmya resulted in a significant improvement in the primary endpoint of reducing daily numeric rating pain scores compared with placebo starting at week 1 until week 14 (p < .0001).⁴ Results from the RESILIENT study confirm findings from the previous RELIEF phase 3 trial, which also showed a statistically significant reduction in fibromyalgia pain with Tonmya sublingual administration.⁵

Patient advocacy groups are excited by this approval. Sharon Waldrop, founder of the Fibromyalgia Association, stated that “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.”¹

With the FDA decision to approve Tonmya, it is estimated to be available to adults in the United States in late 2025. Tonix Pharmaceuticals, the company developing Tonmya, will host a webcast this Monday, August 18, to further discuss the drug’s approval.

References

1. Tonix pharmaceuticals announces FDA approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia. Press release. Tonix Pharmaceuticals. August 15, 2025. Accessed August 15, 2025.

https://ir.tonixpharma.com/news-events/press-releases/detail/1585/tonix-pharmaceuticals-announces-fda-approval-of

2. TNX-102 SL. Tonix Pharmaceuticals. Accessed August 15, 2025. https://www.tonixpharma.com/tnx-102-sl/

3. Lederman S, Arnold LM, Vaughn B, et al. Efficacy and safety of sublingual cyclobenzaprine for the treatment of fibromyalgia: results from a randomized, double-blind, placebo-controlled trial. Arthritis Care Res. 2023;75(11):2359-2368.

4. Iglehart I, Sullivan G, Lederman S. Advancing fibromyalgia treatment: transmucosal sublingual cyclobenzaprine (TNX-102 SL1) targets non-restorative sleep and provides sustained pain reduction. Ann Rheum Dis. 2025;84:492-493.

5. 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 Medicine. 2025;pnaf089.