Tonix Pharmaceuticals (NASDAQ:TNXP) has announced a pivotal advancement in its efforts to bring a new fibromyalgia treatment to market. The company received formal minutes from a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) concerning its drug, Tonmya™ sublingual tablets, aimed at managing fibromyalgia, a chronic condition characterized by widespread pain and fatigue.
The FDA and Tonix agreed that the proposed data package for Tonmya™ is comprehensive and sufficient to support an NDA submission. Tonix Pharmaceuticals has reiterated its plan to submit the NDA to the FDA in the second half of 2024. If the timeline proceeds as intended, this submission could potentially lead to FDA approval in the second half of 2025.
Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, emphasized the promising potential of Tonmya™ to benefit fibromyalgia patients, many of whom are currently dissatisfied with existing treatment options. Presently, a significant number of patients use off-label treatments, including opioids, which are both addictive and potentially harmful. The positive feedback from the pre-NDA meeting highlights the robustness and completeness of the data supporting Tonmya™ for fibromyalgia management.
Tonix Pharmaceuticals is optimistic about the impact Tonmya™ could have on the fibromyalgia treatment landscape. The company remains focused on advancing this promising therapy through the regulatory process to provide a new, effective treatment option for patients struggling with this challenging condition.
