Numinus Congratulates MAPS on its Application to the FDA for MDMA-Assisted Therapy for PTSD
VANCOUVER, BC, Dec. 13, 2023 /CNW/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, congratulates the Multidisciplinary Association of Psychedelics Studies ("MAPS" or "MAPS PBC") for its submission of a new drug application ("NDA") to the U.S. Food and Drug Administration ("FDA") for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.
"This great news for the psychedelic-assisted therapy community and the millions of Americans struggling with PTSD," said Payton Nyquvest, Founder and CEO of Numinus. "In determining the efficacy of MDMA for PTSD, MAPS conducted robust research that included two randomized, double-blind, placebo-controlled Phase 3 studies, with the results published in a peer-reviewed medical journal1, which, if approved, would be the first psychedelic-assisted therapy procedure for PTSD. With its established clinic network and qualified professionals, along with our training pathway, Numinus is ready to offer MDMA-assisted therapy pending regulatory approvals."
As noted in the MAPS release: "With Breakthrough Therapy designation given to MDMA in 2017, MAPS PBC has requested the FDA grant Priority Review of the NDA. The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively). If approved by the FDA, the U.S. Drug Enforcement Agency ("DEA") would be required to reschedule MDMA, making it available for prescription medical use."
Anticipating the demand for MDMA-Assisted Therapy, Numinus has recently expanded its Practitioner Training Program to address the potential shortfall in trained therapists. The entire training program will be migrated to a new Learning Management System platform in January. This will improve learners' engagement, satisfaction, navigation, and community experience. The Company has also launched a free Introduction to Psychedelics course, which will broaden the awareness of the benefits of psychedelic-assisted therapy and build awareness of the complete Numinus training program. More information on the programs can be found on the Numinus website.
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1 Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med 609 2021;27:1025–33 |
Numinus also announces that it has received a notification from OTC Markets Inc. that it no longer satisfies the standards for continued quotation on the OTCQX International tier under the OTCQX Rules for International Companies (the "OTCQX Rules") because the closing bid price of its common shares was below US$0.10 per share for 30 consecutive business days preceding the date of the notification. Pursuant to the OTCQX Rules, Numinus has a grace period of 180 days, or until June 9, 2024, to meet the minimum bid price requirement of US$0.10 per share or higher for at least ten consecutive business days. During the grace period, the Company intends to monitor the closing bid price of its shares and will consider its options in order to regain compliance with the OTCQX minimum bid price requirement or to transition its common shares for quotation on the OTCQB board. The notification does not affect the primary listing of the Company's common shares on the Toronto Stock Exchange and has no immediate effect on the quotation of the common shares on the OTCQX. The shares continue to trade on the TSX under the symbol "NUMI" and continue to be quoted on the OTCQX International tier under the symbol "NUMIF".
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 for 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, Twitter, and Instagram.
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 but not limited to the Company's ability to meet and continue to comply with the standards for continued quotation on the OTCQX International tier, the Company's ability to transfer the quotation of its common shares to the OTCQB or, if so transferred, to meet and continue to comply with the standards for continued quotation on the OTCQB, and the risks set forth in the Company's annual information form dated November 29, 2023, and available on SEDAR+ at www.sedarplus.com. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. The Company 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.
SOURCE Numinus Wellness Inc.
Investor Contact: Craig MacPhail, Investor Relations, [email protected]
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