fda approval

Will Psychedelics Be Rescheduled After FDA Approval?

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).

psychedelics law blog

Webinar Recap: Ketamine Regulations & The Future of Therapeutic Psychedelic Medicines

On April 12th, Hilary Bricken moderated our firm’s webinar titled “Current Ketamine Regulations & The Future of Psychedelic Medicines.” In that webinar, Hilary, Griffen Thorne, and I (Ethan Minkin) discussed the new proposed telehealth regulations from the DEA regarding the Ryan Haight Act of 2008 that will undoubtedly affect the ketamine telehealth industry. We also discussed

salvia divinorum

What’s the Deal with Salvia Divinorum?

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

dmt

DMT Therapy: Coming to a Clinic Near You?

DMT, or N, N-dimethyltryptamine is a powerful psychedelic. DMT, like its sister psychedelics (LSD, MDMA, psilocybin … and even marijuana), is a Schedule I controlled substance. So according to the DEA, its abuse potential is high and it has no medical use. Also, according to the DEA, “the history of human experience probably goes back

psilocybintherapycompasscomp

Is Psilocybin Really a Miracle Drug? Compass Pathways Releases Phase 2B Trial Results

Something strange happened yesterday. Psychedelics unicorn Compass Pathways released data for the largest clinical trial ever conducted of a psilocybin drug. Not only did the drug seem to work, but the heavily anticipated data were “breathtaking” in the words of Compass’ CEO. Immediately, the company’s publicly traded shares dropped 16%. Including the day prior, it

psilocybin controlled substances act reschedule

A Strategy for Rescheduling Psilocybin

Public and scientific interest in psychedelics such as psilocybin and MDMA is expanding. Once off-limits because of federal prohibition, a trickle of research from the 1990s has grown into a stream. But despite increasing acceptance by the public, and commercial investment in psychedelic therapies, aging federal laws stem the flow of vital research. Psilocybin, a

mdma ecstacy fda

MDMA and the FDA Approval Process

Excitement abounds about the status of MDMA, otherwise known as Ecstasy. And for good reason. As noted last month in the New York Times: …those who received MDMA during therapy [in clinical trials] experienced a significantly greater reduction in the severity of their symptoms compared with those who received therapy and an inactive placebo. Two

ketamine off label use

Ketamine and Off-Label Issues

A common question that arises in Ketamine clinic transactions is whether a clinic or physician (collectively, “healthcare providers” or “providers”) can use or promote Ketamine for off-label uses. The short answer is yes, subject to several caveats, as discussed below. However, before reaching the answer, it is important to define what “off-label” use means and

MDMA Ecstasy fda maps

MDMA (Ecstasy) Nears FDA Approval for PTSD Treatment

Efforts by the Multidisciplinary Association for Psychedelic Studies (MAPS) to legalize prescription MDMA (Ecstasy) appear to have passed a gigantic hurdle earlier this month: MDMA is on track to meet the testing requirements to be a legalized prescription drug, specifically intended to treat the symptoms of post-traumatic stress disorder (PTSD). After analyzing the preliminary results

Psilocybin and New Drugs

The “Right to Try” Psilocybin and New Drug Therapies

I was talking to another lawyer about last week’s vote by Oregonians to legalize psilocybin therapy here in the state. We discussed how licensed facilities won’t be up and running for a few more years, and how, in the meantime, people will have to make do with general decriminalization under Measure 109 and maybe, in