Based on FDA guidance emphasizing the importance of demonstrating a persistent treatment effect, Tonix Pharmaceuticals (NASDAQ:TNXP) has changed the timing of the analysis of the primary endpoint of the mean change from baseline in a scale called CAPS-5 to week 12 (from week 4) in its Phase 3 study, RECOVERY, evaluating Tonmya (cyclobenzaprine sublingual tables, 5.6 mg) (formerly TNX-102 SL) for the treatment of posttraumatic stress disorder (PTSD).
Week 12 measurement of CAPS-5, a measurement of PTSD, was used in the Phase 3 HONOR study (that failed) and the Phase 2 AtEase trial (that failed).
It also plans to add an interim analysis with will allow a potential sample size increase of up to 120 subjects.
Preliminary data should be available in Q1 2020 followed by topline results the following quarter.
Shares up 11% premarket on light volume.
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