- Tonix Pharmaceuticals announced earlier this week it has completed an end-of Phase 2/pre-Phase 3 meeting with the U.S. Food and Drug Administration, allowing it to move into late-stage studies of TNX-012 in post-traumatic stress disorder (PTSD).
- The FDA accepted the company's planned trial design for its two Phase 3 studies, one in military patients with PTSD and the other in civilian patients with PTSD. The trial will have the same endpoint as the Phase 2 trials.
- Tonix said the regulatory agency will accept a New Drug Application based on positive results from the two Phase 3 studies, as well as long-term safety exposure studies.
TNX-012 is a reformulation of the muscle relaxant cyclobenzaprine in sublingual form. Tonix is developing the drug for both fibromyalgia and PTSD. It is further along in development for fibromyalgia, with completed Phase 3 studies already under its belt.
The FDA agreed to use the same chemistry, manufacturing and controls (CMC), as well as non-clinical studies it has already accepted for the fibromyalgia NDA.
"We are pleased by the FDA’s response to our completed Phase 2 AtEase study results and encouraged by its agreement on the design of the two Phase 3 studies and our proposed NDA plan," said President and CEO Seth Lederman. "Considering the FDA’s concurrence that the primary endpoint used in the AtEase study will be the same primary endpoint for both upcoming Phase 3 trials, we remain confident in achieving this important milestone."
The first Phase 3 trial in military-related PTSD will begin in the first quarter of 2017, with the second study beginning later in the year. In total, the studies will include 400 to 500 patients.
Just like the Phase 2 AtEase study, the primary endpoint will be the 12-week mean change from baseline in the severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) between those treated with TNX-102 SL and those on placebo.
PTSD affects nearly 8.5 million Americans and results in nightmares, depression and feelings of suicide.