Tonix Pharm (NASDAQ:TNXP) has announced that it has been granted Breakthrough Therapy Designation (BTD) by the FDA as its Phase II AtEase data for TNX-102 SL in military-related PTSD indicate the drug may successfully treat a serious condition, a key requirement for BTD. Key benefits of BTD are intensive guidance from the FDA on the drug development program, an organizational commitment involving senior managers at the FDA, and the submission of portions of the NDA on a rolling basis.
Designation granted for all of PTSD
By granting BTD for the entire indication, the FDA may be signaling that it does not view military-related and civilian post-traumatic stress disorder (PTSD) as fundamentally different and hence only one application will be necessary. Currently, Tonix expects to start a second Phase III in predominantly civilian PTSD sufferers after the start of the HONOR study. While the FDA may not view military and civilian PTSD as different, the trial will likely be required to gain sufficient exposure in female PTSD sufferers.
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