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Breaking Up With Breakthrough: Trevena And Tonix Lose Designation, But Continue With Pivotal Plans

 
• By Bridget Silverman

US FDA rescinds breakthrough designations for Tonix’ PTSD therapy Tonyma and Trevena’s novel pain drug Olinvo after clinical trial disappointments – and after identifying other regulatory pathways to market.

The back-to-back announcements by Tonix Pharmaceuticals Holding Corp. and Trevena Inc. that US FDA had rescinded breakthrough therapy designations (BTDs) suggest the agency is culling the ranks of the popular expedited review program as once-preliminary clinical data mature and, sometimes, alter the balance of safety and efficacy factors that qualified a drug for the designation as a substantial clinical improvement over available therapy.

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