BREAKING NEWS
The US Meals and Drug Administration (FDA) has authorised Tonix Prescription drugs’ Tonmya (cyclobenzaprine HCl, previously often called TNX-102 SL), a novel remedy kind for fibromyalgia.1 The drug is now the primary in a brand new class of non-opioid analgesics for fibromyalgia and the primary new medicine for this dysfunction in 15 years.
The FDA’s approval cited efficacy from 2 double-blind, randomized, placebo-controlled, section 3 medical trials of just about 1000 sufferers that evaluated Tonmya as remedy for fibromyalgia. Throughout each section 3 trials, Tonmya considerably diminished each day ache scores in contrast with placebo on the main endpoint of 14 weeks. In these trials, a larger proportion of sufferers taking Tonmya skilled a clinically significant (≥30%) enchancment of their ache after 3 months, as in contrast with placebo. Throughout section 3 medical trials with over 1,400 sufferers evaluated, Tonmya was typically nicely tolerated. The most typical hostile occasions (incidence ≥2%) included oral hypoesthesia, oral discomfort, irregular product style, somnolence, oral paresthesia, oral ache, fatigue, dry mouth, and aphthous ulcer.
Seth Lederman, MD, chief govt officer of Tonix Prescription drugs, stated the approval “represents a landmark development for the hundreds of thousands of individuals within the U.S. affected by the debilitating ache this situation causes.” He added that “at Tonix, we acknowledged the transformative potential of pursuing a brand new strategy with Tonmya for fibromyalgia, a continual overlapping ache situation, that has gone with out innovation for a few years. We’re hopeful that successfully treating ache with Tonmya might assist enhance the lives of individuals with this continual syndrome.”
Tonmya is a sublingual formulation of cyclobenzaprine (CBP) designed to behave centrally to scale back norcyclobenzaprine (nCBP) to enhance sleep high quality and thereby relieve ache.2 With a sublingual administration, the medicine can act sooner through transmucosal absorption; this absorption avoids first-pass hepatic metabolism and reduces formation of the metabolite nCBP that happens with oral CBP, which is related to hostile results. Tonmya has antagonist actions on the serotonergic, adrenergic, histaminergic, and muscarinic receptors.
Andrea Chadwick, MD, MSc, FASA, on the College of Kansas Well being System weighed in on this novel administration kind: “Remedies which are processed by means of the liver may end up in metabolites that would have an effect on a drugs’s efficacy and security over time. Tonmya is run sublingually which is designed to scale back ache rapidly and durably with a tolerable security profile.”
The drug presently has lively indications as a each day bedtime remedy for posttraumatic stress dysfunction, alcohol use dysfunction, and agitation in Alzheimer illness. Tonmya additionally has been designated Quick Monitor approval by the FDA for agitation in Alzheimer illness.
From a section 1 pharmacokinetic research evaluating oral CBP and Tonmya, investigators discovered that following the primary and final dose of sublingual Tonmya, publicity to CBP and nCBP was lower than with oral CBP capsules.3 In each oral and sublingual administration teams, researchers discovered the identical 9 section I metabolites and eight section II metabolites in participant’s plasma. From a subsequent section 3 RESILIENT research, Tonmya resulted in a big enchancment within the main endpoint of decreasing each day numeric score ache scores in contrast with placebo beginning at week 1 till week 14 (p < .0001).4 Outcomes from the RESILIENT research verify findings from the earlier RELIEF section 3 trial, which additionally confirmed a statistically important discount in fibromyalgia ache with Tonmya sublingual administration.5
Affected person advocacy teams are excited by this approval. Sharon Waldrop, founding father of the Fibromyalgia Affiliation, acknowledged that “for over 15 years, this group has been underserved and ready for brand new remedy choices. This approval is a promising step ahead and brings renewed hope to hundreds of thousands.”1
With the FDA resolution to approve Tonmya, it’s estimated to be obtainable to adults in america in late 2025. Tonix Prescription drugs, the corporate creating Tonmya, will host a webcast this Monday, August 18, to additional focus on the drug’s approval.
References
1. Tonix prescription drugs broadcasts FDA approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the remedy of fibromyalgia. Press launch. Tonix Prescription drugs. August 15, 2025. Accessed August 15, 2025.
2. TNX-102 SL. Tonix Prescription drugs. Accessed August 15, 2025. https://www.tonixpharma.com/tnx-102-sl/
3. Lederman S, Arnold LM, Vaughn B, et al. Efficacy and security of sublingual cyclobenzaprine for the remedy of fibromyalgia: outcomes 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 remedy: transmucosal sublingual cyclobenzaprine (TNX-102 SL1) targets non-restorative sleep and gives sustained ache discount. Ann Rheum Dis. 2025;84:492-493.
5. Lederman S, Arnold LM, Vaughn B, et al. Ache aid by focusing on nonrestorative sleep in fibromyalgia: a section 3 randomized trial of bedtime sublingual cyclobenzaprine. Ache Medication. 2025;pnaf089.