Tonix Pharmaceuticals Receives Positive FDA Feedback for Fibromyalgia Drug Tonmya™
TL;DR
Tonix Pharmaceuticals CEO announced positive FDA feedback for Tonmya sublingual tablets, a potential game-changer in the fibromyalgia treatment market.
The FDA and Tonix Pharmaceuticals have agreed on the comprehensive data package to support the NDA submission for Tonmya, targeting fibromyalgia management.
Tonmya sublingual tablets offer hope to fibromyalgia patients by providing a potentially effective and safer alternative to existing treatment options.
Tonix Pharmaceuticals' positive FDA feedback for Tonmya sublingual tablets signals a potential breakthrough in fibromyalgia treatment, benefiting a vulnerable patient population.
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Tonix Pharmaceuticals (NASDAQ:TNXP) has announced a crucial step forward in the development of their sublingual tablet, Tonmya™, aimed at managing fibromyalgia. The company received formal minutes from a pre-New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA), indicating a positive reception of their proposed data package for the drug.
During this pivotal meeting, both Tonix Pharmaceuticals and the FDA agreed that the data package submitted by the company is comprehensive and sufficient to support the NDA submission. As a result, Tonix Pharmaceuticals is poised to submit the NDA for Tonmya in the second half of 2024. Should the submission proceed as scheduled, it could potentially lead to FDA approval in the latter half of 2025.
Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, emphasized the promising potential of Tonmya to benefit fibromyalgia patients, a group that often finds current treatment options inadequate. Many of these patients resort to off-label treatments, including addictive opioids, due to the lack of effective alternatives. The positive feedback from the pre-NDA meeting highlights the robustness and completeness of the data package that supports the registration of Tonmya for managing 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 to ultimately provide a new, effective option for patients suffering from this challenging condition.
Curated from News Direct
