Tonix announces ‘positive’ pre-NDA CMC FDA meeting onTonmya for fibromyalgia

Tonix Pharmaceuticals Holding announced receipt of the formal minutes from a recent pre-New Drug Application NDA Type-B Chemistry, Manufacturing, and Controls CMC meeting with the U.S. Food and Drug Administration FDA for Tonmya for the management of fibromyalgia. The purpose of the meeting was to seek alignment and agreement with the FDA on key CMC topics to support a planned NDA submission for Tonmya for the management of fibromyalgia. Based on formal written feedback, the Company believes it is aligned with the FDA on key topics, including proposed drug substance and drug product commercial specifications, shelf life assignment, manufacturing and commercial drug packaging. In addition, the Company has completed the second and final pre-NDA meeting for Tonmya with the FDA and discussed nonclinical, clinical pharmacology and clinical matters. The Company awaits formal minutes after which it expects to announce the results of that meeting. The Company remains on track to submit the NDA for Tonmya for the management of fibromyalgia to the FDA in the second half of 2024. “We remain encouraged and excited about the prospect of bringing the first new treatment to market for fibromyalgia patients in over a decade, and this encouraging meeting with the FDA is an important milestone as we head into the final stages of completion of the NDA package,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “During the pre-NDA CMC meeting, the FDA affirmed alignment with Tonix on CMC content and commercial strategy for Tonmya, and we are very appreciative of the FDA’s guidance as we prepare for our NDA submission. We are currently actively preparing a dual manufacturing launch strategy with global contract development and manufacturing organization (CDMO) Almac Pharma Services and another CDMO.”