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 industry

Making Money in the Psychedelics Industry Will be Harder than Cannabis

Anyone familiar with the cannabis industry knows how difficult it is to make money. Things are going to be even worse for people in the state-legal psychedelics industry – much worse. There are a few key reasons for this. I should note that this post is focused on the state-legal psychedelics industry (i.e., service centers)

magic mushrooms

Magic Mushrooms: The Newest Treatment for Athletes?

The use of psilocybin (magic mushrooms) for therapeutic purposes gains traction Last month, the NBA and its players association reached a tentative deal that the league would no longer test players for marijuana. Indeed, the NBA is lifting its ban on marijuana in the new collective bargaining agreement.  Meanwhile, the NFL and its players agreed

DMT

New Brain Scan Study Reveals DMT’s Profound Impact

Among the emerging medical uses for MDMA and psilocybin is their relative dimethyltryptamine (DMT). Although a Schedule I drug in the United States, DMT increasingly is the subject of study for its potential efficacy in treating a wide array of mental-health conditions including depression, anxiety, and PTSD. Much of this research is occurring outside of

free webinar

FREE WEBINAR: Ketamine Regulations & The Future of Therapeutic Psychedelic Medicines

Click HERE to register for our upcoming FREE Q&A webinar on ketamine regulations and the future of therapeutic psychedelic medicines! 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

therapeutic use

Psilocybin and MDMA — Therapeutic Use Permitted in Australia from July 1st 2023

Psilocybin is a naturally occurring psychedelic prodrug compound produced by more than 200 species of fungi. Commonly found in tablet or crystal form, MDMA is a potent psychoactive drug with stimulant properties that produces experiences of empathy and sympathy. Both are currently prohibited in Australia, but will soon be available for therapeutic use. In so

January 12 – Legal and Regulatory Landscape for Psychedelics

Register Here Harris Sliwoski attorneys, Paul Coble, Griffen Thorne, and Vincent Sliwoski, will be presenting on the “Legal and Regulatory Landscape for Psychedelics” in the following CLE webinar on January 12th, 2023, hosted by The Seminar Group. “This program will provide an overview of emerging drug therapies, including psilocybin, ketamine infusion clinics, MDMA and other

psychedelics webinar recap

Psychedelics Webinar Recap

Last week, we presented a psychedelics webinar entitled “How to Protect Your Psychedelics Business.” The panelists were Paul Coble from our Phoenix office), me (Griffen Thorne from our Los Angeles office), and Graham Pechenik of Calyx Law in San Francisco. In the webinar, we presented on business law and intellectual property issues that will affect

psychedelics regulation

States are Missing Out on Psychedelics Regulation

In 2023, Oregon will have a regulated psilocybin market. Colorado voters will have a chance to vote on something similar this fall (although Initiative 58 would not take effect until 2024). Other than that, not a single other state has any form of psychedelic regulation in the works. Last week, an attempt to simply decriminalize

psychedelic drugs

Letter Shows Feds are Gearing Up for Psychedelic Drug Approvals

A recently published letter (“Letter”) indicates that the Biden administration is preparing for the approval of psychedelic drugs and MDMA to treat mental illness and PTSD. This type of federal agency correspondence would have been unimaginable five or six years ago. Things are changing fast! There are well-known potential health benefits of MDMA and psychedelics