Tonix Pharmaceuticals Nears Market Entry with Tonmya for Fibromyalgia Management

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to announce the completion of the initial phase of an assessment conducted by EVERSANA® Life Science Services, LLC on the U.S. market opportunity for Tonmya. Tonmya represents a potential groundbreaking first-line therapy for fibromyalgia management, positioning itself as a non-opioid, centrally-acting alternative in a market dominated by opioids.

Lederman highlighted the concerning dominance of opioids in the fibromyalgia prescription market, despite well-documented risks of dependency. Tonmya aims to address this gap by offering a safer, non-addictive option for fibromyalgia patients. EVERSANA's primary market research indicates promising interest from physicians, with a median interest rating of 4.0 on a 5-point scale and an intended use of Tonmya in 40% of fibromyalgia patients upon approval. The analysis also noted that approximately 50% of fibromyalgia patients in the U.S. are on Medicare. The Inflation Reduction Act, effective in 2025, will cap out-of-pocket prescription drug costs for Medicare patients, which could improve access to Tonmya if approved.

With the submission of the New Drug Application (NDA) for Tonmya slated for the second half of the year, Tonix Pharmaceuticals anticipates an FDA decision on approval by 2025.