BREAKING NEWS
The US Meals and Drug Administration granted Transcend Therapeutics with the Breakthrough Remedy designation for his or her compound TSND-201 for (methylone) for the therapy of posttraumatic stress dysfunction (PTSD) following constructive outcomes from its IMPACT-1 research.1
In March 2025, Transcend shared the outcomes of IMPACT-1, a randomized placebo managed scientific trial that evaluated efficacy of TSND-201 within the therapy of PTSD. The trial consisted of 65 individuals who had extreme PTSD as outlined as Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) ≥ 35 and had tried earlier therapy. Members obtained 4 oral doses of the agent or placebo and had been monitored for 64 days after the preliminary dose. The research met the first endpoint with placebo-adjusted CAPS-5 enchancment of -9.64 factors on Day 64 (-23.28 factors vs. -13.64 factors; p = 0.011). Furthermore, enhancements had been seen as early as day 10, with a statistically important placebo-adjusted CAPS-5 enchancment of -8.00 factors (-17.83 factors vs. -9.83 factors; p = 0.012). Importantly, the development was sturdy for the size of the research.2
IMPACT-1 additionally demonstrated a superb security and tolerability profile. A lot of the reported adversarial occasions had been transient and occurred on the day that the participant obtained the dose, and most occasions resolved that very same day. Headache, decreased urge for food, nausea, dizziness, elevated blood stress, dry mouth, insomnia, muscle tightness, and feeling irregular had been probably the most generally reported occasions. A affected person with a historical past of seizures additionally reported a seizure 7 days after the final dose; the occasion was not thought-about associated to the TSND-201. The corporate added that it had “a security profile according to its non-hallucinogenic pharmacology.”2
Thought of a quickly performing neuroplastogen, TSND-201 is Transcend Therapeutics’ proprietary type of methylone. The monoamine transporters are thought-about its main website of motion, and the corporate reviews no exercise at 5HT-2a.2
“This designation underscores the pressing want for brand spanking new, more practical therapies for the 13 million Individuals residing with PTSD,” Blake Mandell, co-founder and CEO of Transcend Therapeutics, stated in a press release to the press. “Solely two FDA-approved drugs can be found in the present day—and no new PTSD therapies have been accredited in over 20 years. This Breakthrough Remedy designation permits us to work extra intently with the FDA as we put together to launch our Section 3 program.”1
Murray B. Stein, MD, MPH, distinguished professor of psychiatry and public well being on the College of California San Diego and a Transcend advisor, was equally excited concerning the designation and its which means for sufferers. “The present therapy commonplace, SSRIs, can take as much as 12 weeks to point out maximal impact and infrequently trigger uncomfortable side effects throughout that point. Even then, many sufferers on SSRIs do not get enough profit,” he stated in a press assertion. “A rapid-acting, sturdy therapy for PTSD could be a paradigm shift in psychiatry—and provide a possible lifeline for sufferers.”
“This designation affords new hope that sooner, more practical therapy could also be inside attain,” Stein added.1
After practically 2 a long time with no new therapy for PTSD, there was renewed hope final yr when Lykos’ MDMA-assisted remedy was reviewed by the FDA. Veterans and first responders advocates advocated for cautious consideration on the time, noting “PTSD is without doubt one of the few psychiatric problems that reliably predicts suicidal ideation, suicide makes an attempt, and suicide mortality, considerably contributing to our nation’s veteran suicide epidemic, which claims between 17 and 44 veteran lives each day.”3 Sadly, approval on the time was not granted.
References
1. Transcend Therapeutics Receives Breakthrough Remedy Designation for TSND-201 (methylone) for the Remedy of PTSD. Press launch. Jul 10, 2025. Accessed July 10, 2025. https://www.prnewswire.com/news-releases/transcend-therapeutics-receives-breakthrough-therapy-designation-for-tsnd-201-methylone-for-the-treatment-of-ptsd-302501928.html
2. Transcend Therapeutics Broadcasts Major Endpoint Met in IMPACT-1 Section 2 Research of TSND-201 in PTSD. Press launch. March 31, 2025.
3. Duerr HA. Officers, Veterans Urge Cautious Consideration for MDMA-Assisted Psychotherapy. Psychiatric Occasions. August 8, 2024. Accessed July 10, 2025. https://www.psychiatrictimes.com/view/officials-veterans-urge-careful-consideration-for-mdma-assisted-psychotherapy
