Tonix Pharmaceutical’s Tonmya approved: first fibromyalgia drug in 15 years

Tonix Pharmaceuticals CEO Seth Lederman talked with Proactive's Stephen Gunnion about the FDA approval of Tonmya, the first new fibromyalgia treatment in over 15 years. Lederman described Tonmya as a "first in class medicine" with a different mechanism of action from the three currently approved drugs for fibromyalgia. The approval is the result of a 15-year development journey, during which the company took the product from concept to clinical trials and now to market authorisation. Tonmya is indicated for the long-term treatment of fibromyalgia in adults, including geriatric patients and those with mild hepatic impairment. It is administered as a sublingual tablet at bedtime and works by addressing the non-restorative sleep component of fibromyalgia. The product is not an opioid and is therefore not associated with dependence or abuse. “We are treating a chronic pain condition, but Tonmya itself is not an opioid,” Lederman noted. Tonix plans to launch the drug in Q4 2025. Lederman explained that the company will first target the 2.7 million US patients who are already diagnosed and treated. He added that 5% of healthcare providers diagnose 70% of fibromyalgia cases, making this group a priority for engagement. Visit Proactive’s YouTube channel for more interviews. Don’t forget to like the video, subscribe, and turn on notifications for updates. #TonixPharmaceuticals #Tonmya #FibromyalgiaTreatment #FDAApproval #NonOpioid #ChronicPain #BiotechNews #PharmaUpdate #ProactiveInvestors #DrugDevelopment