Allay Therapeutics’ ATX101 Secures the US FDA’s Breakthrough Therapy Designation to Treat Post-Surgical Pain
Shots:
- The US FDA has granted BTD to ATX101 for treating adults with post-surgical pain following total knee replacement surgery
- Designation was based on dose-ranging P-II exploratory study of ATX101 vs bupivacaine (SoC) in 112 subjects, showing sustained pain relief for up to 2wks., decreased opioid use & associated side effects plus improved functional activities & satisfaction for up to 60 days. A regitrational P-IIb trial in 200 individuals is planned in 2025 across the US
- ATX101 is an investigational formulation of bupivacaine (intracellular sodium ion channel blocker) and a biopolymer indicated for relieving pain post total knee arthroplasty (TKA)
Ref: Bussineswire | Image: Allay Therapeutics
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
