Transcend Therapeutics has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to TSND-201, a rapid-acting neuroplastogen, for the treatment of post-traumatic stress disorder (PTSD).
The designation is based on preliminary clinical evidence suggesting substantial improvement over existing therapies, aiming to expedite development and review timelines for promising treatments.
The breakthrough therapy designation is supported by positive results from the IMPACT-I study.
This Phase II trial was a randomised, placebo-controlled study involving 65 patients with severe PTSD.
TSND-201 demonstrated rapid, robust and durable improvements in PTSD symptoms, with statistically significant improvements by day 10 and sustained effects through to day 64.
Transcend Therapeutics co-founder and CEO Blake Mandell stated: “This designation underscores the urgent need for new, more effective treatments for the 13 million Americans living with PTSD.
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By GlobalData“Only two FDA-approved medications are available today 鈥� and no new PTSD treatments have been approved in over two decades. This breakthrough therapy designation enables us to work more closely with the FDA as we prepare to launch our Phase 3 programme.”
University of California San Diego professor of psychiatry and public health and a Transcend consultant Murray B Stein stated: “A rapid-acting, durable treatment for PTSD would be a paradigm shift in psychiatry 鈥� and offer a potential lifeline for patients.
“The current treatment standard, SSRIs, can take up to 12 weeks to show maximal effect and often cause side effects during that time. Even then, many patients on SSRIs don’t get adequate benefit. This designation offers new hope that faster, more effective treatment may be within reach.”
TSND-201 is a proprietary formulation of methylone developed by Transcend Therapeutics. It has well-characterised primary pharmacology, acting primarily at monoamine transporters, with no hallucinogenic activity. Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD and other central nervous system indications.
PTSD is a mental health condition that can occur after experiencing or witnessing a life-threatening or traumatic event. Symptoms include flashbacks, nightmares, severe anxiety and uncontrollable thoughts about the event.
PTSD affects 13 million Americans annually, with almost 7% of US adults estimated to be diagnosed during their lifetime.
