Tue Dec 24 2024

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 N...