Tonix Pharmaceuticals Holding Corp.(NASDAQ:TNXP) which is advancing a next-generation therapy for PTSD, reported that the U.S. FDA has granted Breakthrough Therapy status to TNX-102 SL* for the cure of posttraumatic stress disorder.
The advantages of Breakthrough Therapy designation comprise the eligibility for priority assessment of the New Drug Application within 6 months and rolling submission of parts of the NDA, besides an organizational commitment comprising FDA’s senior managers offering significant guidance. The U.S. FDA is committing to offer Tonix interactive communications and timely advice linked to the design and execution of a drug development plan.
The expert speaks
Seth Lederman, M.D., the CEO and President of Tonix, said that they are extremely delighted to get Breakthrough Therapy designation for TNX-102 SL targeting PTSD. This decision highlights the FDA’s acknowledgement that PTSD is a grave disease, and that initial clinical evidence from Phase II AtEase trial in military-related PTSD boosts TNX-102 SL’s prospective benefit over currently-accessible PTSD treatments.
The timeline for the production of commercial offering to support a Breakthrough Therapy filing aligns with company’s TNX-102 SL registration program. As they prepare to commence their Phase III HONOR trial in 1Q2017, they anticipate benefiting from the FDA’s promise to expedite the advancement and assessment of TNX-102 SL for PTSD by involving senior staff in a collaborative and proactive effort.
They consider that their joint commitment to boost the registration and development of TNX-102 SL can probably offer patients with PTSD, covering patients with military-related PTSD, an enhanced treatment alternative in the speediest manner possible.
Since TNX-102 SL is stated as a Breakthrough Therapy, they expect obtaining FDA remarks on the HONOR trial protocol and suggested interim assessment plan imminently. They proposed 2 preliminary studies for the HONOR trial as part of an adaptive plan, an approach suggested by the FDA to quicken the establishment of clinical indication of efficacy to back a Breakthrough Therapy nod.