A group of prominent researchers and clinicians have published a consensus statement backing the use of MDMA-assisted therapy for post-traumatic stress disorder (PTSD). This statement comes as FDA is reviewing a New Drug Application for midomafetamine (MDMA) for the condition. “On the basis of the safety and efficacy data we have seen, assuming the integrity…
MDMA’s potential shift from party drug to PTSD therapy could hinge on strict safety measures
MDMA, the stimulant mood-lifting drug commonly known as ecstasy, could soon transition from party staple to FDA-approved medication — but likely with tight control measures to address its abuse potential and safety risks. On Tuesday, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) filed an application seeking FDA approval of MDMA-assisted therapy for post-traumatic stress…
More than a century after its synthesis, MDMA could be headed for FDA approval for PTSD
First synthesized in 1912 by Merck, the empathogenic drug 3,4-Methylenedioxymethamphetamine (MDMA) is inching toward FDA approval following the positive results of a phase 3 study. The recently concluded phase 3 study, MAPP2, published in Nature Medicine, found that MDMA-assisted therapy significantly outperforms traditional talk therapy in reducing PTSD symptoms. Participants receiving MDMA-AT had an 86.5%…
MAPS predicts FDA approval for MDMA-assisted therapy in 2024
The Multidisciplinary Association for Psychedelic Studies (MAPS) founder and executive director, Rick Doblin, said in an interview with Fox Business Live that the FDA would approve MDMA-assisted therapy for PTSD in April or May of 2024. Last year, MAPS announced the completion of the MAPP2 Phase 3 study, which is the organization’s second to use MDMA (3,4-methylenedioxymethamphetamine)…
MindMed announces Phase 1 study of MDMA-like substances
On the heels of launching a Phase 2b study of LSD in generalized anxiety disorder, MindMed (Nasdaq: MNMD) has dosed the first subject in a Phase 1 study evaluating MDMA-like substances in healthy volunteers. MindMed is developing a synthetic enantiomer of MDMA as a potential treatment for core symptoms of autism spectrum disorder (ASD). Early…
FDA could approve MDMA and psilocybin in 2 years
To deal with a worsening mental health crisis in the U.S., the FDA is reportedly considering approving 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin within the next two years, according to a letter from a Substance Abuse and Mental Health Services Administration (SAMHSA) published by The Intercept. MDMA could be authorized as a treatment for post-traumatic stress disorder, while…
As interest in psychedelic medicine grows, Big Pharma sits on the sidelines
While Big Pharma has yet to embrace psychedelics as potential treatments for depression and other psychiatric disorders, interest in psychedelic medicine is building. Earlier this month, Nature Medicine published a Phase 3 study indicating that psychotherapy assisted with methylenedioxymethamphetamine (MDMA) was a more effective treatment for post-traumatic stress disorder (PTSD) than therapy alone. The study authors concluded…