Tonix Pharma Gets FDA Written Guidance On Phase 3 Program For TNX-102 SL

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) said it has received written guidance from the U.S. Food and Drug Administration or FDA on its Phase 3 clinical study design for TNX-102 SL in fibromyalgia.

Seth Lederman, president and chief executive officer of Tonix Pharma said, "Getting this confirmation from the FDA - particularly its acceptance of the 30 percent responder analysis as the primary outcome measure - represents a clear step forward in our ongoing development of TNX-102 SL in fibromyalgia."

Tonix Pharma's lead candidate, TNX-102 SL, is intended to be a first-line treatment for fibromyalgia and for post-traumatic stress disorder or PTSD.

Tonix Pharma noted that the 30 percent responder analysis is defined as an improvement in pain, as measured by the number of subjects who achieve at least a 30 percent improvement in their pain scores.

In the Phase 2b BESTFIT study, TNX-102 SL demonstrated a statistically significant improvement in the 30 percent responder analysis, which was a pre-specified secondary outcome measure.

Tonix Pharma said it is on track to begin the Phase 3 clinical study in the second quarter of 2015.