Tonix Pharmaceuticals Receives FDA Approval for Tonmya, a New Treatment for Fibromyalgia

Tonix Pharmaceuticals has received FDA approval for Tonmya, a drug for fibromyalgia. Tonmya is the first new treatment for the condition in over 15 years. It is a cyclobenzaprine sublingual tablet, taken under the tongue. The approval marks a significant milestone for the company and offers a new option for patients with fibromyalgia.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has announced a significant milestone in the treatment of fibromyalgia with the FDA approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets). This approval marks the first new FDA-approved therapy for fibromyalgia in over 15 years, offering a much-needed advancement for the millions of Americans suffering from this chronic pain condition.

Fibromyalgia is a complex disorder characterized by widespread pain, fatigue, and sleep disturbances, affecting an estimated 10 million adults in the U.S., with women making up approximately 80% of the cases. Tonmya, a first-in-class, non-opioid, once-daily bedtime analgesic, is designed to provide rapid absorption through a unique sublingual formulation, bypassing first-pass hepatic metabolism. This formulation reduces the production of a long half-life active metabolite, norcyclobenzaprine, enhancing the drug's efficacy and safety profile.

The FDA approval is based on the results of two pivotal Phase 3 clinical trials, RELIEF and RESILIENT, which enrolled nearly 1,000 patients. These trials demonstrated that Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks and achieved a greater percentage of clinically meaningful pain improvements. The drug was generally well tolerated, with common adverse events including oral hypoesthesia, oral discomfort, and somnolence.

The approval of Tonmya represents a significant breakthrough for patients and healthcare providers. Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, noted, "The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this condition causes." Sharon Waldrop, founder of the Fibromyalgia Association, echoed this sentiment, expressing hope that the new treatment could improve the lives of people with fibromyalgia.

Tonmya is expected to be commercially available for adult patients in the U.S. with fibromyalgia in the fourth quarter of 2025. Tonix Pharmaceuticals will host a webcast and conference call on Monday, August 18, 2025, at 8:30 AM ET to discuss the approval further. For more information, visit TonmyaHCP.com or download the TONMYA Fact Sheet.

Tonix Pharmaceuticals is a fully-integrated biotechnology company focused on central nervous system disorders, immunology, immuno-oncology, and infectious diseases. This FDA approval is a testament to Tonix's commitment to developing innovative treatments for chronic conditions.

References:
[1] https://ir.tonixpharma.com/news-events/press-releases/detail/1585/tonix-pharmaceuticals-announces-fda-approval-of