Transcend Therapeutics, a clinical-stage biotech focused on neuropsychiatric treatments, announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational drug TSND-201 (methylone) for Post-Traumatic Stress Disorder (PTSD).
The designation is based on positive Phase 2 trial results from IMPACT-1, a randomized, placebo-controlled study of 65 patients with severe PTSD. TSND-201 demonstrated rapid, robust, and sustained symptom improvements by Day 10, with effects lasting through Day 64. The drug was well tolerated, showing no hallucinations or treatment discontinuations due to adverse events.
“Only two FDA-approved treatments exist for the 13 million Americans with PTSD, and no new therapies have been approved in over 20 years,” said Blake Mandell, Transcend’s co-founder and CEO. “This Breakthrough Therapy status will help us work closely with the FDA as we advance to Phase 3.”
Dr. Murray B. Stein of UC San Diego, a consultant to Transcend, highlighted the potential impact: “Current SSRIs can take up to 12 weeks to work and often don’t provide adequate relief. A rapid-acting, durable treatment like TSND-201 could transform PTSD care and offer hope to many patients.”
The Breakthrough Therapy pathway is designed to accelerate development and review of promising treatments for serious conditions. Transcend plans to leverage this designation as it prepares for late-stage clinical trials.