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Tonix Pharmaceuticals Announces Data Presentations on TNX-102 SL for Fibromyalgia at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS 2024)
Tonix Pharmaceuticals presented data on TNX-102 SL for fibromyalgia at the PDDS 2024 conference. The presentations highlighted the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL, a sublingual cyclobenzaprine HCl tablet. Key points include:
1. Patents based on TNX-102 SL's eutectic composition are expected to provide market exclusivity until at least 2034.
2. FDA New Drug Application (NDA) submission is on track for October 2024, with Fast Track designation granted.
3. The Phase 3 RESILIENT studydemonstrated statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain and all six key secondary endpoints.
4. TNX-102 SL's formulation allows for efficient transmucosal absorption and targeting of disturbed sleep.
5. In vitro tests have been developed to support manufacturing processes and product uniformity.
1. Patents based on TNX-102 SL's eutectic composition are expected to provide market exclusivity until at least 2034.
2. FDA New Drug Application (NDA) submission is on track for October 2024, with Fast Track designation granted.
3. The Phase 3 RESILIENT studydemonstrated statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain and all six key secondary endpoints.
4. TNX-102 SL's formulation allows for efficient transmucosal absorption and targeting of disturbed sleep.
5. In vitro tests have been developed to support manufacturing processes and product uniformity.
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