Over the last few weeks, the federal government has taken a number of actions that signal a dark future for psychedelic therapies. Today we’ll take a quick look at what’s happened, and what may happen in the future. FDA gives thumbs down to MDMA Earlier in August, the FDA opted not to approve Lykos Therapeutics’
A new age for psychedelics We are on the verge of a psychedelic renaissance, with the Food and Drug Administration (FDA) accepting a new drug application for midmafetamine (MDMA) in February of this year. MDMA the active ingredient in the common party drug “ecstasy” or “molly”. If approved, the drug would be used to treat
Despite decades of stigma and legal barriers, recent years have brought a profound shift in attitudes towards psychedelics. Driven by scientific inquiry and a growing recognition of their potential therapeutic benefits, the benefits of psychedelics are being explored. In this blog post, we explore the impact of an unexpected catalyst driving progress in psychedelics research–
On February 16, 2022 and October 10, 2023, the FDA issued two warnings about the use of compounded ketamine. The first warning is entitled, “FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray,” and the second warning is entitled, “FDA warns patients and health care providers about potential risks associated
Perhaps inevitably, lawmakers introduced a very skinny bill last week to protect states that legalize psilocybin from federal intervention. Specifically, it requires that: [n]o Federal funds may be used to prevent any State or unit of local government from implementing such State’s or unit of local government’s own laws that authorize the use, distribution, sale,
Ketamine telehealth has been a wild ride these last few years. Every few months I give an update, and every time I do, things seem to change dramatically. For example, in just a few short weeks in February 2023, the situation went from “bad” to “good” (at least sort of) as it became clear that
A handful of entities are in various stages of the FDA approval process for MDMA and psilocybin drugs (see here and here for some of our prior analysis of the issues). FDA approval could happen in the next few years. But there’s a catch: psilocybin and MDMA are both schedule I drugs under the Controlled Substances Act (CSA).
A few weeks ago, we held a webinar about ketamine regulation and the future of psychedelic medicine (for a recording, click here). At the time, there were big changes on the horizon for ketamine telehealth. In the last few weeks, there have been a few pretty significant developments that merit some attention. For some background,
There are lots of psychedelics and psychedelic adjacent substances that are not scheduled under the Controlled Substances Act (CSA). Recently I wrote about amanita muscaria mushrooms and their legal status. Today, I want to talk about a different one: salvia divinorum. Salvia divinorum Salvia divinorum is a psychedelic substance. It was often used for religious
In the next few years, the FDA will likely approve drug formulations containing psilocybin and MDMA. While there are still many unknowns concerning how psilocybin and MDMA-based drug therapies will be regulated, we believe that many of the same trends we have seen over the last few years in ketamine therapy will apply to these
