Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share positive Phase 3 data on Tonmya, also known as TNX-102 SL, for the management of fibromyalgia, and discussed the company's plans to file for FDA approval in the second half of 2024.
Dr. Lederman highlighted that Tonmya, a centrally acting, non-opioid, non-addictive bedtime medication, showed promising results in the RESILIENT Phase 3 study. The study met its pre-specified primary endpoint by significantly reducing daily pain compared to placebo in participants with fibromyalgia.
Additionally, significant improvements were observed in key secondary endpoints related to sleep quality, fatigue reduction, and overall fibromyalgia symptoms and function.
Based on these positive results, Tonix Pharmaceuticals plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia.
The company hosted a webinar featuring key opinion leaders in fibromyalgia, highlighting the significance of the trial results. Interested individuals can access the webinar through Tonix Pharmaceuticals' website or the accompanying press release. Led by renowned experts like Professor Leslie Arnold and Professor Dan Clau, the webinar offers valuable insights into the treatment landscape for fibromyalgia. Tonix Pharmaceuticals remains committed to advancing innovative solutions for fibromyalgia and improving patient outcomes.
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