Saving MDMA VII: This isn't The First Drug to Have Problems Getting Approved
A bedtime story about another first-in-class drug.
The Frontier Psychiatrists is a daily enough health-themed newsletter. Recently, I've done quite a bit of writing around the FDA approval process for the Lykos Theraputics Breakthrough Submission of MDMA-AT. That stands for MDMA-assisted therapy. The pretense is that this breakthrough treatment is a combination of an old off-patent drug, MDMA, and manualized Psychotherapy. I've already written about how I think the therapeutic component of this is not good. Like others, I have written about some of the very serious problems in the clinical trials from both an ethics and an FDA perspective. Here are those prior articles—subscribe! Some are behind a paywall now—you snooze, am I right?
The “Saving MDMA” Series!
To put my dime down, I don't think MDMA-AT will be approved by the FDA when it …