FDA

Tonmya approved for fibromyalgia

August 20, 2025

Brand name: Tonmya

Generic name: cyclobenzaprine sublingual

Manufacturer: Tonix Pharmaceuticals

Approval date: August 15, 2025

FDA approved Tonmya (cyclobenzaprine HCl sublingual [SL] tablets) for the treatment of fibromyalgia in adults.

According to a manufacturer press release, Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic with a SL formulation designed for rapid absorption into the bloodstream.

Efficacy

Approval was based on data from two double-blind, randomized, placebo-controlled, phase 3 trials (RELIEF [NCT04172831] and RESILIENT [NCT05273749]) involving nearly 1,000 patients that evaluated Tonmya as a bedtime treatment for fibromyalgia. Across both trials, Tonmya significantly reduced daily pain scores vs. placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after three months, vs. placebo. In a third phase 3 trial (RALLY [NCT04508621]), no statistically significant difference was seen between Tonmya and placebo.

Safety

Across three all phase 3 trials (N >1,400), Tonmya was generally well tolerated. The most common adverse reactions (incidence ≥2% and greater than placebo) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

Sources:

Tonix Pharmaceuticals announces FDA approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia. [News release]. 2025. https://ir.tonixpharma.com/news-events/press-releases/detail/1585/tonix-pharmaceuticals-announces-fda-approval-of

Tonmya (cyclobenzaprine HCl sublingual tablets) [package insert]. Tonix Pharmaceuticals. https://www.tonixpharma.com/wp-content/uploads/2025/08/Tonmya-Prescribing-Information.pdf