Psilocybin and MDMA Get the Green Light for Medical Use in Canada

NEW YORK, Jan. 19, 2022 /PRNewswire/ -- After facing legal scrutiny for decades, psychedelics including MDMA and psilocybin received a stamp of approval from Health Canada for medical purposes. Canada's legislation now permits the use of psychedelics beyond palliative care, something health advocates are calling a major breakthrough in treating serious or life-threatening conditions. This news is great for patients interested in psychedelic treatments for mental illness and will likely offer companies Compass Pathways (NASDAQ:CMPS), ATAI Life Sciences (NASDAQ:ATAI), Revive Therapeutics Ltd. (OTCQB:RVVTF), Mind Medicine (MindMed) (NASDAQ:MNMD) (NEO:MMED), and Numinus Wellness (TSX:NUMI) (OTCPK:NUMIF) who are conducting clinical trials on various psychedelics a smoother pathway to approval.

Numinus Wellness (TSX:NUMI) (OTC:NUMIF) helps people heal through the development and delivery of innovative mental health care. This includes access to safe, evidence-based psychedelic-assisted therapies. The company's business model focuses on psychedelic production, research, and clinical care to heal symptoms for illnesses such as depression, anxiety, trauma, pain, and substance use.

On January 18, Numinus Wellness announced that it has completed the necessary steps to begin enrolling participants for its MAPS Public Benefit Corporation study, a multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX). The study received regulatory approval from Health Canada, along with ethical approval from an Institutional Review Board (IRB). It was also granted a Section 56 exemption from the Controlled Drug and Substance Act to allow the use of MDMA to test the safety and efficacy in treating severe PTSD throughout the duration of the clinical trial.

MAPS is the leading developer of MDMA-assisted therapy training programs, treatment protocols, and research. In December, Science Magazine designated MAPS' MDMA-assisted therapy for PTSD among its top ten Scientific Breakthroughs of the Year in 2021. Numinus will host the Canadian sites for MAPPUSX in Quebec and British Columbia, which will be managed through Numinus' two new, purpose-designed clinics, allowing for quick completion of the MAPS trial in Canada.

Numinus Wellness, which recently graduated to the TSX, also just announced that it has submitted the clinical trial application (CTA) to Health Canada for its Phase 1 study, HOPE, on a naturally derived Psilocybe extract formulation, NBIO-01. This milestone solidifies and further progresses the company's long-standing work on developing safe and effective psychedelic products out of its Health Canada-licensed research facility, Numinus Bioscience.

For more information on Numinus Wellness (TSX:NUMI) (OTC:NUMIF), please visit this link.

Approvals, Trials, and Progress in New Treatments Using Psychedelics

Compass Pathways (NASDAQ:CMPS) is a mental health care company accelerating patients' access to innovation in mental health. On January 4, the company shared results of a Phase 1 study displaying the feasibility of administering COM360 psilocybin to up to six healthy participants simultaneously. This study was an initial demonstration that the simultaneous administration of psilocybin is worth exploring further.

Atai Life Sciences (NASDAQ:ATAI) is a clinical-stage biopharmaceutical company transforming the treatment of mental health disorders. On January 12, the company announced that the Food and Drug Administration (FDA) gave the company Investigational New Drug (IND) clearance to conduct a clinical DDI study of PCN-101 (R-ketamine). The study is planned to begin in early 2022 through Atai's platform company Perception Neuroscience. atai sees this as a promising candidate for a potentially rapid-acting antidepressant with more favourable safety and tolerability than S-ketamine. This could eventually enable at-home use, for patients who require ketamine treatment for severe depression or other mental illnesses.

Revive Therapeutics (OTCQB:RVVTF) (CSE:RVV) provided the status of its Phase 3 clinical trial for Bucillamine in COVID-19, revealing that 700 participants took part in the enrollment period. The specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders. By Mid-February, Revive expects to begin subject enrollment in Turkey, and to complete enrollment in the Phase 3 clinical trial sometime in Q1 2022. The company's advancement of this trial and its potential COVID-19 treatment will continue to be reported in the coming quarters as the Phase 3 trial continues.

Mind Medicine Inc. (NASDAQ:MNMD) (NEO:MMED) just completed its Phase clinical trial of 18-MC, which is a non-hallucinogenic proprietary derivative of ibogaine. The company is developing this treatment for indications linked to opioid use disorder. Completed in December 2021, the topline results of the trial are expected in early 2022. This marks another milestone for the trial, and the company will also announce the results of the Phase 1 study in the coming months, according to Robert Barrow, Chief Executive Officer and Director of MindMed.

Disclaimer:  Microsmallcap.com (MSC) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. FN Media Group (FNM) is a third-party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated with MSC or any company mentioned herein. The commentary, views and opinions expressed in this release by MSC are solely those of MSC and are not shared by and do not reflect in any manner the views or opinions of FNM. Readers of this Article and content agree that they cannot and will not seek to hold liable MSC and FNM for any investment decisions by their readers or subscribers. MSC and FNM and their respective affiliated companies are a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.

The Article and content related to the profiled company represent the personal and subjective views of the Author (MSC), and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author (MSC) has not independently verified or otherwise investigated all such information. None of the Author, MSC, FNM, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer's filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer's securities, including, but not limited to, the complete loss of your investment. FNM was not compensated by any public company mentioned herein to disseminate this press release but was compensated twenty five hundred dollars by MSC, a non-affiliated third party to distribute this release on behalf of Numinus Wellness

FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MSC and FNM undertake no obligation to update such statements.

Media Contact:

FN Media Group, LLC
[email protected]
+1(561)325-8757

SOURCE Microsmallcap.com