Tonix showcases Phase 3 data for FDA-approved Tonmya at PAINWEEK 2025, eyes launch next quarter

Tonix Pharmaceuticals Holdings CEO Dr Seth Lederman joined Steve Darling from Proactive to share that the company presented four scientific posters at the PAINWEEK 2025 conference in Las Vegas, Nevada, showcasing robust data from two pivotal Phase 3 trials of Tonmya® for the treatment of fibromyalgia. The first study, RELIEF, was a 14-week randomized, double-blind, placebo-controlled trial, while the second, RESILIENT, served as a confirmatory efficacy and safety trial. Results across both studies demonstrated that Tonmya significantly reduced fibromyalgia-related pain while maintaining a favorable tolerability profile. Unlike conventional pain therapies, Tonmya is designed to pharmacologically target nonrestorative sleep by antagonizing receptors that regulate sleep architecture—addressing a central mechanism thought to perpetuate fibromyalgia symptoms. Dr. Lederman noted that beyond reducing pain, Tonmya’s mechanism of action may help improve a wide spectrum of fibromyalgia symptoms, potentially supporting earlier diagnosis, timely intervention, and improved long-term outcomes. Importantly, the therapy represents a non-opioid treatment option at a time when safer alternatives are in high demand. With FDA approval secured, Tonix is now preparing to launch Tonmya commercially in the coming quarter, marking a transformative milestone for both the company and the fibromyalgia community. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #Biotech #TonixPharmaceuticals #Tonmya #Fibromyalgia #FDAApproval #NonOpioid #PainManagement #ChronicPain #NociplasticPain #Cyclobenzaprine #MoveFibroForward #Painweek2025