VANCOUVER, BC, Aug. 12,
2024 /PRNewswire/ - Numinus Wellness Inc.
("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a leader
in mental health care specializing in innovative and evidence-based
treatments, comments on the U.S. Food and Drug Administration's
("FDA") decision to not approve Lykos Therapeutics' new drug
application for MDMA (midomafetamine capsules) used in combination
with psychological intervention for individuals with post-traumatic
stress disorder ("PTSD"). According to a news release issued by
Lykos Therapeutics, the FDA has requested that an additional Phase
3 study be conducted to study the safety and efficacy of MDMA
further.
"While this is a blow to all the incredibly positive and
encouraging work that has been done to advance safe access to
psychedelic therapy, which MAPS and Lykos have led the charge for,
we remain unwavering and committed to doing all we can to make
these important therapies available for all those suffering who
need it most," said Payton Nyquvest, Numinus Founder and CEO.
"We're confident that further study will continue to show the
efficacy of MDMA, and with many psychedelic compounds at the late
stages of research, the pipeline of treatments to address severe
conditions remains strong."
"For Numinus, we will continue to execute on our previously
announced plan to achieve profitability with our existing
operations, which were and continue not to be dependent on the
commercialization of new therapies," Mr. Nyquvest added.
Spravato® (esketamine) and ketamine continue to be
available to practitioners to treat mental health conditions, and
Numinus Wellness clinics have delivered over 43,600 such treatments
to patients. The clinics have built an optimized business model
with best-in-class patient care, including a call center and
expertise in reimbursed billing. The company is working to leverage
its leadership into an offering available to mental health
professionals across the U.S. Through Cedar Clinical
Research, Numinus has conducted clinical research involving
four psychedelic medicines administered through different
modalities involving over 50 subjects over the past 2.5 years. At
the same time, its comprehensive practitioner training program
prepares the Numinus team and trainees to treat patients across
multiple medications and modalities, including ketamine and
MDMA.
"The FDA decision demonstrates the high level of scrutiny that
psychedelic compounds receive and the continuing requirement for
comprehensive, rigorous research as some of these investigational
products move through late-stage clinical trials," said Dr.
Paul Theilking, Numinus Chief
Science and Medical Officer. "We're proud of our clinical trials
work with major psychedelic drug developers and will continue to be
a committed research partner as more compounds are advanced."
Letter of intent with MedBright AI
Numinus also
announces that it has terminated the letter of intent previously
announced on June 20, 2024, to
acquire MedBright AI Investments Inc.
About Numinus
Numinus Wellness Inc. (TSX: NUMI) helps people to heal and be
well through the development and delivery of innovative mental
health care and access to safe, evidence-based psychedelic-assisted
therapies. The Numinus model – including psychedelic research and
clinic care – is at the forefront of a transformation aimed at
healing rather than managing symptoms of depression, anxiety,
trauma, pain and substance use. At Numinus, we are leading the
integration of psychedelic-assisted therapies into mainstream
clinical practice and building the foundation for a healthier
society.
Learn more at www.numinus.com and follow us
on LinkedIn, Facebook, and Instagram.
Forward-looking statements
Statements and other information contained in this press
release about anticipated future events constitute forward-looking
statements. Forward-looking statements are often, but not always,
identified by the use of words such as "seek", "anticipate",
"believe", "plan", "estimate", "expect", and "intend" and
statements that an event "may", "will", "should", "could" or
"might" occur or other similar expressions. Forward-looking
statements are subject to risks and uncertainties and other factors
that could cause actual results to differ materially from those
contained in the forward-looking statements, including the results
of further research into MDMA, if any, the FDA and other
regulators' decisions in respect of MDMA and other psychedelic
medications, restrictions that may be placed on the use of
psychedelic compounds by regulatory authorities; safety and
efficacy of psychedelic-assisted therapy; acceptance, uptake and
commercialization of psychedelic-assisted therapy, if any;
dependence on obtaining regulatory approvals, and other risks that
are set forth in our annual information form dated November 29, 2023, and available on SEDAR at
www.sedarplus.ca. Forward-looking statements are
based on estimates and opinions of management at the date the
statements are made. Numinus does not undertake any obligation to
update forward-looking statements even if circumstances or
management's estimates or opinions should change except as required
by applicable laws. Investors should not place undue reliance on
forward-looking statements.
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SOURCE Numinus Wellness Inc.