Summary by Moomoo AI
Tonix Pharmaceuticals announced FDA acceptance of its New Drug Application for TNX-102 SL, a non-opioid analgesic for fibromyalgia management. The FDA is expected to assign a PDUFA target action date and decide on Priority Review status in the upcoming Day 74 Letter. TNX-102 SL received Fast Track designation in July 2024.The NDA is supported by two successful Phase 3 trials, RELIEF and RESILIENT, which demonstrated significant pain reduction compared to placebo. TNX-102 SL was generally well-tolerated with no new safety signals. If approved, it would be the first new fibromyalgia drug in over 15 years, potentially benefiting over 10 million U.S. adults affected by the condition.Tonix aims to address the unmet needs of fibromyalgia patients, noting that 18 months post-diagnosis, patients are more likely prescribed opioids than FDA-approved drugs. The company is advancing commercial preparations for a potential 2025 launch, leveraging its existing commercial team supporting migraine treatments Zembrace SymTouch and Tosymra.
