PsyCan Comments on FDA Decision Re: Lykos MDMA-Assisted Therapy Application

PsyCan, the not-for-profit trade association for the legal Canadian psychedelic medicine, today commented on the U.S. Food and Drug Administration (“FDA”) decision on the New Drug Application by Lykos Therapeutics for MDMA and MDMA-assisted therapy to treat PTSD.

“While the FDA’s decision is a setback for the approach taken by Lykos, this result cannot be generalized to MDMA-assisted therapy or psychedelic-assisted therapies at large,” said PsyCan Executive Director Liam Bedard.

“There are dozens of ongoing studies investigating MDMA, novel MDMA formulations, and a range of other psychedelic medicines as therapies for a variety of indications in clinical trials overseen by academic institutions and companies here in Canada and around the world. Several psychedelic drugs have received FDA designations enabling additional consultation on clinical design earlier in their respective trial phases, which are not precluded by the issues raised in Lykos’ case.”

Numerous landmark scientific articles now demonstrate the safety and efficacy of psychedelic drugs for mental health conditions like anxiety, depression, post-traumatic stress, and substance-abuse disorders. These findings have led to a series of positive international regulatory developments: more than 30 U.S. states have introduced psychedelics-related bills, and last year Australia's medicines regulator approved the use of psychedelic drugs to assist therapy sessions.

Health Canada’s Special Access Program (SAP) has also allowed applications for the medical use of psilocybin and MDMA since 2022. However, timelines for review have been inconsistent and outcomes unpredictable, unnecessarily increasing stress on critically and chronically ill Canadians.

“Given recent international developments and the growing mountain of clinical evidence, it’s a matter of when, not if, psychedelic medicine and therapy will be approved. That’s why we have been calling on the Canadian government to take a proactive, rather than reactive approach to regulating psychedelic medicine and therapy,” said Bedard.

“Ultimately, these developments underscore the urgent need to improve Canada’s service standards under the SAP for Canadian patients and to develop a standalone medical psychedelic access program. PsyCan would also welcome a Federal Task Force on developing psychedelic access models for Canadian patients who stand to benefit from these treatments.”

About PsyCan

Incorporated as the Psychedelics Businesses Association, PsyCan is the not-for-profit trade association of legally operating psychedelic medicine and therapy companies in Canada. PsyCan is dedicated to working collaboratively to advance government regulation, scientific research, and the specific needs of the growing sector. Its member companies represent research, development, manufacturing, and clinic operations. At the time of incorporation, PsyCan was the first national-level trade association for the legal psychedelic medicine and therapy sector anywhere in the world.

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