Tonix Pharmaceuticals (NASDAQ:TNXP) CEO Dr Seth Lederman joined Steve Darling from Proactive to announce the receipt of formal minutes from a pre-New Drug Application (NDA) meeting with the US FDA regarding Tonmya sublingual tablets, which is aimed at managing fibromyalgia. This significant development marks a crucial step forward in the regulatory process for Tonmya™.

During the meeting, both the company and the FDA concurred that the proposed data package is comprehensive and sufficient to support the NDA submission. Tonix Pharmaceuticals has reaffirmed its plan to submit the NDA for Tonmya to the FDA in the second half of 2024. If the submission proceeds as planned, it could pave the way for a potential FDA approval in the second half of 2025.

Dr Lederman highlighted the promising potential of Tonmya to benefit fibromyalgia patients, a demographic that frequently expresses dissatisfaction with existing treatment options. Many patients currently resort to using off-label treatments, including addictive and detrimental opioids, due to the lack of effective alternatives. The positive outcomes from the pre-NDA meeting underscore the robustness and completeness of the data package that supports the registration of Tonmya for the management of fibromyalgia.

Tonix Pharmaceuticals is optimistic about the impact that Tonmya could have on the fibromyalgia treatment landscape. The company's focus remains on advancing this promising therapy through the regulatory process and ultimately providing a new, effective option for patients struggling with this challenging condition.

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