PsyCan comments on FDA decision regarding Lykos MDMA-assisted therapy application

OTTAWA, Ontario, August 9, 2024 (GLOBE NEWSWIRE) — PsyCanthe non-profit organization for legal Canadian psychedelic medicines, today commented on the U.S. Food and Drug Administration’s (“FDA”) decision on Lykos Therapeutics’ New Drug Application for MDMA and MDMA-assisted therapy for the treatment of PTSD.

“While the FDA’s decision is a setback for Lykos’ approach, this finding cannot be generalized to MDMA-assisted therapy or psychedelic therapies in general,” said Liam Bedard, CEO of PsyCan.

“There are dozens of ongoing studies investigating MDMA, novel MDMA formulations, and a range of other psychedelic drugs 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 that allow for additional consultation on clinical design earlier in their respective trial phases, which is not precluded by the issues raised in the Lykos case.”

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

Since 2022, Health Canada’s Special Access Program (SAP) has also allowed applications for the medical use of psilocybin and MDMA. However, review times are inconsistent and outcomes are unpredictable, unnecessarily increasing the stress for seriously and chronically ill Canadians.

“Given recent international developments and the growing body of clinical evidence, it is a matter of when, not if, psychedelic medicines and therapies will be approved. That is why we have called on the Canadian government to take a proactive, rather than reactive, approach to regulating psychedelic medicines and therapies,” Bedard said.

“Ultimately, these developments underscore the urgent need to improve Canadian service standards under the SAP for Canadian patients and develop a standalone medical psychedelic access program. PsyCan would also welcome a federal task force focused on developing psychedelic access models for Canadian patients who may benefit from these treatments.”

About PsyCan

PsyCan, founded as the Psychedelics Businesses Association, is the non-profit trade association of legally operating psychedelic medicine and therapy businesses in Canada. PsyCan is dedicated to working together to advance government regulation, scientific research, and the specific needs of the growing industry. Member companies represent research, development, manufacturing, and clinic operations. At the time of its founding, PsyCan was the first national trade association for the legal psychedelic medicine and therapy industry in the world.

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