The FDA has approved Tonmya (cyclobenzaprine HCl sublingual), a non-opioid, once-daily, bedtime therapy designed for rapid absorption, for the treatment of fibromyalgia in adults. It is the first new FDA-approved fibromyalgia therapy in more than 15 years.
Approval was supported by two double-blind, randomized, placebo-controlled Phase 3 trials (nearly 1,000 patients) showing significant pain reduction versus placebo at 14 weeks, the primary endpoint. A greater proportion of patients receiving Tonmya achieved ≥30% pain improvement at three months. Across three Phase 3 trials involving more than 1,400 patients, Tonmya was generally well tolerated.
Common adverse reactions included oral hypoesthesia, oral discomfort, abnormal taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer. Contraindications include hypersensitivity to cyclobenzaprine; recent or concomitant MAOI use; acute recovery from myocardial infarction; certain cardiac conduction issues; congestive heart failure; and hyperthyroidism. Key warnings address embryofetal toxicity risk around conception, serotonin syndrome with serotonergic agents, tricyclic antidepressant–like effects (arrhythmias, lowered seizure threshold), anticholinergic effects, CNS depression, and oral mucosal reactions.
Dose reduction is recommended in mild hepatic impairment; use is not recommended in moderate or severe hepatic impairment. Safety and effectiveness have not been established in pediatric patients, and data in older adults are insufficient.
Tonmya is expected to be commercially available in the fourth quarter of 2025.
Source: Tonix Pharmaceuticals
