FDA Approves Tonmya for Chronic Pain Condition, First New Therapy in Over 15 Years

Tonix Pharmaceuticals Holding Corp.'s TNXP Tonmya drug has been approved by the FDA for fibromyalgia treatment in adults. This is the first new FDA-approved therapy for fibromyalgia in over 15 years. Tonmya is a non-opioid, once-daily bedtime analgesic with a unique sublingual formulation. The drug was approved after two Phase 3 clinical trials with nearly 1,000 patients showed significant pain reduction compared to placebo. Tonmya is expected to be available in the US in Q4 2023.

Tonix Pharmaceuticals Holding Corp. (TNXP) has received approval from the U.S. Food and Drug Administration (FDA) for Tonmya™ (cyclobenzaprine HCl sublingual tablets) to treat fibromyalgia in adults. This marks the first new FDA-approved therapy for fibromyalgia in over 15 years [1].

Fibromyalgia is a chronic pain condition affecting more than 10 million adults in the U.S., predominantly women [1]. Tonmya, a first-in-class, non-opioid, once-daily bedtime analgesic, offers a unique sublingual formulation designed for rapid absorption into the bloodstream [1].

Two pivotal Phase 3 studies, RELIEF and RESILIENT, demonstrated that Tonmya significantly reduced fibromyalgia pain compared to placebo [1]. Across both trials, Tonmya showed a greater percentage of participants experiencing clinically meaningful pain reduction after three months compared to placebo. The drug was generally well tolerated, with the most common adverse events including oral hypoesthesia, oral discomfort, and somnolence [1].

Tonmya is expected to be commercially available in the U.S. in the fourth quarter of 2023 [1]. The company will host a webcast and conference call on Monday, August 18, 2025, at 8:30 AM ET to discuss the approval [1].

References:
[1] https://finance.yahoo.com/news/tonix-pharmaceuticals-announces-fda-approval-194400374.html