Transcend Therapeutics, a clinical-stage biotechnology company that develops medicines to treat neuropsychiatric diseases, announced on Thursday that the US Food & Drug Administration (FDA) has granted Breakthrough Therapy designation to TSND-201 (methylone) for the treatment of Post-Traumatic Stress Disorder (PTSD).

Breakthrough Therapy designation is granted if preliminary clinical evidence shows that a treatment may demonstrate substantial improvement over available therapy.

The Breakthrough Therapy designation is based on the positive results from IMPACT-1, a randomised, placebo-controlled, Phase 2 clinical trial evaluating TSND-201, a rapid-acting neuroplastogen, for the treatment of PTSD. IMPACT-1 was a randomised, placebo-controlled Phase 2 trial of 65 patients with severe PTSD. The company says that TSND-201 achieved rapid, robust and durable improvements in PTSD symptoms. Statistically significant and clinically meaningful symptom improvements occurred by Day 10 (-8.00 placebo-adjusted CAPS-5 improvement) with effects sustained through Day 64 (-9.64 placebo-adjusted CAPS-5 improvement). TSND-201 was well tolerated, with no hallucinations or discontinuations due to adverse events.