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Tonix Pharmaceuticals Holding Corp. Announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TNX-102 SL* for the treatment of posttraumatic stress disorder (PTSD).
The benefits of Breakthrough Therapy designation include the eligibility for priority review of the New Drug Application (NDA) within 6 months instead of 10 months and rolling submission of portions of the NDA, in addition to an organizational commitment involving FDA's senior managers contributing significant guidance. The FDA is committing to provide Tonix timely advice and interactive communications related to the design and efficient execution of a drug development program.
“We are very pleased that the FDA has granted Breakthrough Therapy designation to TNX-102 SL for PTSD,” stated Seth Lederman, M.D., president & chief executive officer of Tonix. “This decision reflects the FDA’s recognition that PTSD is a serious disease, and that preliminary clinical evidence from our Phase 2 AtEase study in military-related PTSD supports TNX-102 SL’s potential advantage over currently-available PTSD therapies. In addition to being Phase 3-ready, the timeline for the manufacturing of commercial product to support a Breakthrough Therapy application aligns with our TNX-102 SL registration plan. As we prepare to initiate our Phase 3 HONOR study in the first quarter of 2017, we look forward to benefiting from the FDA’s commitment to expedite the development and review of TNX-102 SL for PTSD by intensively involving senior staff in a proactive and collaborative effort. We believe our joint commitment to accelerate the development and registration of TNX-102 SL can potentially provide patients with PTSD, including those with military-related PTSD, an improved treatment option in the most expeditious manner possible.”
Tonix held a successful End-of-Phase 2/Pre-Phase 3 meeting with the FDA in the third quarter of this year, based on positive data from its 12-week randomized, double-blind, placebo-controlled Phase 2 AtEase study. Tonix plans to begin enrolling patients into its first Phase 3 study, the HONOR study, in the first quarter of 2017 after receiving FDA agreement on the study design and interim analysis plan.
“Since TNX-102 SL is designated as a Breakthrough Therapy, we anticipate receiving FDA comments on the HONOR study protocol and proposed interim analysis plan imminently. We proposed two interim analyses for the HONOR study as part of an adaptive design, an approach recommended by the FDA to accelerate the establishment of clinical evidence of efficacy to support a Breakthrough Therapy approval,” stated Gregory Sullivan, M.D., chief medical officer of Tonix.
