Tonmya FDA approval

Tonmya is a non opioid sublingual tablet approved to treat fibromyalgia in adults, with a late 2025 commercial launch planned.

Tonmya marks first new fibromyalgia drug in 15 years

Tonmya, a cyclobenzaprine HCl sublingual tablet, has been approved by the FDA for the treatment of fibromyalgia in adults. The drug is described as a first in class non-opioid bedtime analgesic with rapid absorption under the tongue, designed to be taken once daily at night. The approval relies on two Phase 3 trials, RELIEF and RESILIENT, involving nearly 1,000 participants, which showed a significant reduction in daily pain scores at 14 weeks and a higher rate of patients achieving a 30% or greater improvement in pain. In broader testing across more than 1,400 patients, Tonmya was generally well tolerated, with common adverse events including mouth numbness, altered taste, drowsiness, and dry mouth. Tonix expects Tonmya to become available in the fourth quarter of 2025, with safety warnings tied to interactions with other serotonergic drugs and certain cardiovascular factors.

The approval signals a potential shift in fibromyalgia care by embracing a non-opioid, sleep-focused approach. Yet the path to routine uptake will hinge on cost, reimbursement, and how payers value a new class of therapy in a condition that has long limited options. The clinical data show real pain reduction for many, but questions remain about long term safety in broad use, adherence to a nightly dosing schedule, and how Tonmya fits with existing non pharmacological strategies. As with any breakthrough, the hit will be measured not just in trials but in patient access and real world outcomes.

Highlights

The coming months will test how much patients benefit from innovation when it meets price and coverage constraints.