PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.
Emerge’s Hot Take
Trouble for Ecstasy? What MDMA’s FDA Setback Could Mean for Psychedelics
Last week, the FDA advisory committee recommended against the approval of Lykos Therapeutics’ MDMA-assisted therapy for patients with PTSD. The proposed treatment was purported to be the first new drug application for psychedelic-assisted therapy ever submitted to the FDA. The committee cited allegations of ethical misconduct (which Lykos strenuously denies) and broader concerns over challenges with “functional unbinding” (a standard for many research studies ensuring that participants do not know if they are being administered the placebo or test drug). Proponents of approval, however, point out that the difficulty in meeting this standard is not unique to psychedelics, and that many current FDA-approved psychoactive drugs faced similar research design issues. Proponents further note that while allegations of misconduct are certainly concerning, such unsubstantiated allegations are not typically supposed to be factored into committee recommendations, and that committee critiques of the “experimental” approach of the specific form of talk therapy offered in combination with the drug unfairly mischaracterize what is essentially an already widely accepted form of talk therapy. Researchers are also expressing concern over the committee’s belief that not much is known about MDMA’s toxicity, which has been well-studied, and skepticism over the committee’s assertion that patients may be more likely to “seek out illegal drugs such as cocaine after taking MDMA.” The recommendation of the committee does not necessarily preclude FDA approval of MDMA-assisted therapy. The agency may instead opt for a stricter set of requirements once the drug is on the market, or request that Lykos perform another clinical trial before granting approval. The agency may also decide to approve the application as is.
“With 10 of 11 committee members determining that Lykos’ clinical trial did not prove that the benefits of MDMA outweigh the risks, we are reminded of the deeply established medical container that psychedelics companies are functioning within”, says Emerge attorney Kaci Hohmann. “There is much insight to be gained from the committee’s discussions and concerns, and much more work to be done to orient our existing medical system and professionals to novel approaches to our population’s urgent mental health needs.”
Other Noteworthy News
New York Bill Would Legalize Psilocybin for Adults Who Obtain Permits
MARIJUANA MOMENT – “A top New York lawmaker has introduced a bill to legalize psilocybin for adults, provided they obtain a permit after undergoing a health screening and educational course. The legislation, sponsored by Assembly Health Committee Chair Amy Paulin (D), is one of the latest examples of New York legislators moving to enact psychedelics reform amid a growing state-by-state movement across the country. Under the bill, the state Department of Health would regulate the program, licensing psilocybin cultivators and providing psilocybin permits to adults. There would be a mandatory educational course lasting up to five hours and a health screening requirement in order to obtain a permit. With a permit, adults could lawfully grow, possess, use and share psilocybin with other permitted adults. The use, cultivation and sale of psilocybin without a license or permit would be treated as a “violation” under state statute, meaning the maximum penalty would be a $250 fine and up to 15 days in jail. To that end, it would not broadly decriminalize the psychedelic as other bills have sought, but it would reduce the penalty. The bill has been referred to the Assembly Health Committee, which is chaired by the sponsor.”
Magic Mushrooms Get Canadian Export License in Psychedelic Race
BLOOMBERG – “Canada’s health department awarded a drug establishment license to Optimi Health Corp., a spokeswoman for the company said, allowing it to ship pills containing the magic-mushroom extract psilocybin and MDMA — controlled and otherwise-illegal substances — to a provider in Australia. The small Vancouver-based company hopes the certificate will help pave the way to an expanded market for psychedelic drugs as pharmaceuticals while giving it an early-mover advantage. Optimi’s bet is that, even though magic mushrooms are naturally occurring, demand for a pharmaceutical-grade version of the substance will be robust, and the company will have the credentials and scale to supply it. To grow, test, and extract its trippy crop, Optimi has set up 20,000 square feet of facilities in Princeton, British Columbia, a mining and lumber town with a population of about 3,000 in the mountains three hours’ drive east of Vancouver.”
Medical Psilocybin Bill Advances
NJ SPOTLIGHT NEWS – “New Jersey lawmakers [on 6/6/24] shelved a plan to decriminalize the use of psilocybin in favor of a bill only allowing its use for therapeutic purposes and in preventive behavioral health treatment. Lawmakers voted on the bill [known as the Psilocybin Behavioral Health Access and Services Act] to approve using psilocybin in health care, swapping that version for one on their agenda that would have decriminalized the drug and called for expungement for past offenses involving the possession, use and distribution of psilocybin. The last-minute change by state lawmakers comes amid increasing public support for the legalization of the drug for therapeutic purposes and a growing body of research pointing to psilocybin’s effectiveness in treating major depressive disorder and alcohol-use disorder, among other mental health and substance use issues. [The Act] has bipartisan support and passed the Senate Health, Human Services and Senior Citizens Committee by a vote of 6-2.”
LISTEN: One Year Later – Oregon’s Psilocybin Industry is Maturing and Progressing
KLCC: OREGON ON THE RECORD – “On this edition of Oregon On The Record, [OOTR] checks in with Cathy Jonas of EPIC Healing Eugene, the very first psilocybin service center to receive a license in Oregon, and finds out how its going.”
LISTEN: FDA Panel Rejects Attempt to Use Psychedelic Drugs for PTSD Treatment
PBS NEWS HOUR – “A key FDA advisory committee rejected the use of a psychedelic drug to help patients struggling with PTSD, questioning its safety and effectiveness. The FDA must now decide whether it will follow suit and reject the use of what’s known as MDMA. Some patients and researchers had long hoped the government would approve it. PBS science correspondent, Miles O’Brien, covered the day-long [advisory] hearing.”
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