PsyCan Comments on FDA Decision Re: Lykos MDMA-Assisted Therapy Application
09 August 2024 - 11:28PM
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.
psycan.orgadmin@psychedelicscanada.org 1
Adelaide Street East Suite 801 Toronto, ON M5C 2V9