Tonix Pharmaceuticals reports final pre-NDA meeting with FDA for Tonmya

Tonix Pharmaceuticals Holding announced receipt of the formal minutes from a recent pre-New Drug Application meeting with the U.S. Food and Drug Administration for Tonmya for the management of fibromyalgia. At the meeting, the Company and the FDA agreed that the proposed data package is sufficient to support the NDA submission. The Company reaffirmed its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024 which would allow for a potential FDA approval in the second half of 2025. “We are delighted with the results of this critical milestone meeting with the FDA to discuss our NDA, and we are appreciative of the FDA’s guidance throughout this process. We believe Tonmya has the potential to greatly benefit fibromyalgia patients, many of whom remain dissatisfied with the current treatment options, and many of whom turn to addictive, detrimental opioids as off-label treatments,” said Seth Lederman, CEO. “The positive results from this pre-NDA meeting underscore the completeness of our data package in support of registration of Tonmya for the management of fibromyalgia.” On June 20, 2024, Tonix announced receipt of formal minutes of a pre-NDA Type-B Chemistry, Manufacturing, and Controls meeting confirming alignment with the FDA on key CMC topics to support the NDA submission. Today’s announcement confirms alignment with the nonclinical, clinical pharmacology and clinical features of the NDA submission, following completion of Tonix’s second and final pre-NDA meeting.