Tonix Pharmaceuticals Holding Corp. has announced that its medication, Tonmya, has demonstrated significant reduction in fibromyalgia pain compared to a placebo in the Phase 3 RESILIENT study. The treatment was well-tolerated, with minimal effects on weight or blood pressure, and a discontinuation rate of 19% compared to 20.8% for the placebo. These results support the potential of Tonmya as a well-tolerated, centrally acting, non-opioid analgesic for adults with fibromyalgia.
The RESILIENT study was a 14-week randomized, double-blind, placebo-controlled trial conducted at 34 US sites, involving 456 participants who met the 2016 American College of Rheumatology criteria for fibromyalgia. The results showed that Tonmya resulted in a statistically significant reduction in weekly average pain scores at Week 14, as well as significant improvements in sleep quality, fatigue, and symptoms and function domains of the Fibromyalgia Impact Questionnaire.
Tonmya was approved by the FDA on August 15, 2025, for the treatment of fibromyalgia in adults. The medication is a first-in-class, non-opioid analgesic that is administered sublingually at bedtime. Tonix Pharmaceuticals believes that Tonmya has the potential to provide clinically meaningful pain reduction while remaining well-tolerated, making it a valuable treatment option for adults with fibromyalgia.
The company’s CEO, Seth Lederman, stated that fibromyalgia is a debilitating condition that impacts over 10 million adults in the US, and existing treatments are limited by tolerability and side effects. He believes that Tonmya’s ability to provide pain reduction while being well-tolerated reinforces its value as a differentiated treatment for fibromyalgia.
Tonix Pharmaceuticals is a fully integrated biotechnology company with a pipeline of development candidates focused on central nervous system disorders, immunology, immuno-oncology, rare disease, and infectious disease. The company has received FDA approval for Tonmya and is also developing other treatments, including TNX-102 SL for acute stress reaction and acute stress disorder, and TNX-1500 for the prevention of allograft rejection and treatment of autoimmune diseases.
The safety and efficacy of Tonmya have been established in clinical trials, and the medication is contraindicated in patients with hypersensitivity to cyclobenzaprine or any inactive ingredient, as well as in patients with certain medical conditions, such as arrhythmias, heart block, or congestive heart failure. The most common adverse reactions associated with Tonmya include oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.