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A Phoenix Turn For Tonix: Rising From Phase III Ashes With New PTSD Approach

 
• By Lucie Ellis-Taitt

In an exclusive interview, Seth Lederman, CEO of New York-based Tonix Pharmaceuticals, talks about the company’s R&D rollercoaster ride and how it plans to keep its lead asset on track for approval as a treatment for post-traumatic stress disorder. 

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Rising from Phase III ashes with an action plan, Tonix will pursue lead drug in PTSD • Source: Shutterstock

It has been a bumpy journey for Tonix Pharmaceuticals Holding Corp. trying to get its lead investigational compound, TNX-102 SL, to market – despite the drug having Breakthrough Therapy status in the US for the treatment of post-traumatic stress disorder (PTSD). In an exclusive interview with In Vivo, CEO of the New York-based company, Seth Lederman, talks about Tonix’s R&D rollercoaster ride and how it hopes to keep its lead asset on track for approval.

In July 2018, Tonix was forced to stop early a Phase III trial for TNX-102 SL, also known as Tonmya (cyclobenzaprine HCl sublingual tablets). Preliminary safety data did not reveal any serious or unexpected adverse events in the trial, but benefit to patients was not significant over placebo

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