Curated News
By: NewsRamp Editorial Staff
July 18, 2024
Tonix Pharmaceuticals Receives Positive FDA Feedback on Tonmya for Fibromyalgia Management
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- 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.
Impact - Why it Matters
This news matters as it signifies a crucial step forward in the regulatory process for Tonmya sublingual tablets, potentially providing a new, effective treatment option for fibromyalgia patients.
Summary
Tonix Pharmaceuticals CEO Dr Seth Lederman announced the receipt of formal minutes from a pre-New Drug Application meeting with the US FDA regarding Tonmya sublingual tablets for fibromyalgia management. The company and the FDA agreed that the proposed data package is comprehensive and sufficient to support the NDA submission. Tonix Pharmaceuticals plans to submit the NDA in the second half of 2024, potentially leading to FDA approval in the second half of 2025.
Dr Lederman highlighted the potential of Tonmya to benefit fibromyalgia patients who are dissatisfied with existing treatment options. The positive outcomes from the pre-NDA meeting underscore the robustness of the data package supporting the registration of Tonmya. The company remains focused on advancing this promising therapy through the regulatory process and providing a new, effective option for patients struggling with fibromyalgia.
Source Statement
This curated news summary relied on this press release disributed by News Direct. Read the source press release here, Tonix Pharmaceuticals Receives Positive FDA Feedback on Tonmya for Fibromyalgia Management
