Tonix Pharmaceuticals achieves key milestone with FDA review timeline for Fibromyalgia treatment

Proactive - Interviews for investors

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to announce an important milestone for the company’s New Drug Application (NDA) for a novel fibromyalgia treatment. The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, marking the anticipated timeline for a decision on marketing approval. The treatment is a non-opioid, centrally acting therapy designed to address fibromyalgia, a chronic and debilitating pain condition that disproportionately affects women and impacts over 10 million adults in the United States. Highlighting the significance of the FDA collaboration, Dr. Lederman stated, “We believe this therapy has the potential to become the first in a new class of medicines for managing fibromyalgia.” Data from pivotal Phase 3 trials demonstrated meaningful pain reduction with a favorable safety profile, addressing an urgent unmet need in the fibromyalgia patient community. The NDA submission is supported by data from two 14-week, double-blind, randomized, placebo-controlled Phase 3 clinical trials, which confirmed the treatment's efficacy and tolerability with no new safety concerns. Previously granted Fast Track designation by the FDA in July 2024, the therapy is recognized for its potential to transform the fibromyalgia treatment landscape. If approved, this innovative therapy would be the first new drug for fibromyalgia in more than 15 years, offering hope to millions of patients seeking effective and tolerable treatment options. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #FibromyalgiaTreatment #FDAApproval #TNX102SL #NonOpiateTherapy #PharmaNews #DrugDevelopment #ProactiveInvestors#invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews