Viviana D. Evans, Alejandro Arenas, Kenneth Shinozuka et al.
preprint
Background: Ketamine, an arylcyclohexylamine dissociative anesthetic agent, has evolved into a versatile therapeutic. It has a rapid onset, well-understood cardiovascular effects, and a favorable safety profile in clinical use. Its enantiomeric compound, esketamine, was approved by the FDA in 2019 for both treatment-resistant depression as well as major depressive disorder (MDD) with suicidal...
Kenneth Shinozuka, Burton J. Tabaac, Alejandro Arenas et al.
preprint
Background: After becoming notorious for its use as a party drug in the 1980s, 3,4-methylenedioxy-methampetamine (MDMA), also known by its street names “molly” and “ecstasy,” has emerged as a powerful treatment for post-traumatic stress disorder (PTSD). Areas of uncertainty: There is extensive data about the risk profile of MDMA. However, the literature is significantly biased. Animal models...
Balázs Szigeti, Ellen Bradley, Joshua Woolley
preprint
On August 9th the US Food and Drug Administration’s (FDA) rejected 3,4-methylenedioxymethamphetamine assisted therapy (MDMA-AT) as a treatment for post-traumatic stress disorder (PTSD), despite seemingly positive trial results. A major reason cited was functional unmasking, which combined with enthusiasm about MDMA, raised concerns about the objectivity of these trials. Here, we define what is...
L. J. Flameling, Jacob S. Aday, Michiel van Elk
1 citation
preprint
In their recent paper titled “MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial”, Mitchell et al.1 report on the results from a study researching the potential use of 3,4-methylenedioxy methamphetamine-assisted therapy (MDMA-AT) for the treatment of posttraumatic stress disorder (PTSD). We applaud the efforts made to further establish the efficacy...
SSRN Electronic Journal
Vincent Joralemon
preprint
MDMA is currently a Schedule I controlled substance, the most restrictive category under the Controlled Substances Act. But Lykos Therapeutics' (formerly MAPS PBC) pending New Drug Application for MDMA-assisted therapy as a treatment for PTSD may force the Drug Enforcement Administration's hand: FDA approval supplies the "accepted medical use" that Schedule I drugs are statutorily denied,...
Balázs Szigeti
1 citation
preprint
On August 9th the US Food and Drug Administration’s (FDA) rejected 3,4-methylenedioxymethamphetamine assisted therapy (MDMA-AT) as a treatment for post-traumatic stress disorder (PTSD) despite seemingly positive trial results. A major reason cited was functional unmasking, which combined with enthusiasm about MDMA, raised concerns about the objectivity of these trials. Here, we define what is...