Numinus Announces Milestones In Compassionate Access Trial For MDMA-Assisted Therapy In Collaboration With MAPS Public Benefit Corporation
Ryan Allway
February 19th, 2021
Psychedelics
Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted psychotherapies, is pleased to share that the single-arm, open-label, compassionate access1 trial for MDMA-assisted therapy has made significant progress towards treating patients with posttraumatic stress disorder (PTSD). This trial is being pursued in collaboration with MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), the leading developer of the treatment protocols, research, and MDMA-assisted therapy training programs.
“We are excited to share an update on the progress of our MDMA compassionate access trial with the full recognition that existing therapies for PTSD are inadequate,” said Payton Nyquvest, CEO of Numinus. “At Numinus, we are pleased to help foster a promising regulatory landscape that will contribute to a better understanding that psychedelic-assisted psychotherapies are a viable, safe, and necessary avenue for expanding existing treatment options. We look forward to continued collaboration with the Multidisciplinary Association of Psychedelics for Studies (MAPS PBC) and will work together to provide those experiencing PTSD with more treatment options.”
This first-of-its-kind trial in Canada has advanced and successfully transitioned into the pre-implementation stage at Numinus’ Vancouver clinic. This follows the successful completion of several milestones, starting with the recruitment of therapists, physicians, and staff in preparation for participant enrolment and the ultimate analysis of therapy outcomes. The highly qualified cohort of medical staff will be responsible for collecting safety data for Health Canada to further implement key research that supports individuals living with PTSD who have not benefited from existing treatment options.
In November 2020, eight Numinus therapists graduated from Part B of the MAPS MDMA therapist training program. Through their roles within the trial, they will complete the supervision requirement for certification as fully qualified MDMA therapists.
A draft MDMA-assisted therapy protocol for PTSD has been adapted for the trial, including clear guidance surrounding necessary screening processes, patient health histories, and indications and potential contraindications before accepting participants. Initial regulatory meetings with Health Canada to define the trial’s implementation science strategy have been completed, and the next steps will include obtaining ethical and Health Canada approvals to allow the recruitment of participants according to COVID-19 public health protocols.
“Developing a skilled workforce is a key challenge for the safe delivery of psychedelic-assisted therapies, so we are pleased to engage with Numinus to train therapists in the MDMA-assisted therapy protocol for PTSD,” said Amy Emerson, CEO of MAPS PBC.
Numinus is also pleased to announce that its Medical and Therapeutic Services Director, Dr. Devon Christie, will serve as both the trial’s Principal Investigator and as a therapist. Dr. Christie is a family physician with a focus in multidisciplinary pain management, is a certified Relational Somatic Therapist, and is already MAPS-trained in the delivery of the MAPS MDMA-assisted therapy for PTSD.
“I am thrilled to be involved in a long-awaited clinical program that will help pave the way towards wider use of MDMA-assisted psychotherapy for those experiencing PTSD,” said Dr. Christie. “The key milestones announced today are a true testament to our teams’ commitment to establishing the physical, technical, clinical, and human resource infrastructure needed to swiftly move through the trial’s formal implementation stages and ultimately towards the recruitment of the first participant.”
NOTE
The safety and efficacy of MDMA-assisted psychotherapy is currently under investigation. It has not yet been approved by Health Canada or the FDA, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or FDA approval or availability of MDMA-assisted psychotherapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.
1Health Canada recommends compassionate access open-label clinical trials when drug manufacturers anticipate exceptional demand for a drug, “to meet the needs of patients not eligible for enrollment in other pivotal trials” (Special Access Program for Drugs: Guidance document for industry and practitioners, Published 2020-10-14). This program is not related to the U.S. FDA Expanded Access program, sometimes referred to as “compassionate use” or the Breakthrough Therapy designation.
About Numinus
Numinus Wellness Inc. (TSXV:NUMI) is a health care and research company creating psychedelic-centred solutions to treat mental illness, substance abuse and trauma.
Numinus Health delivers treatments through clinics and virtual services, with clinics in Vancouver and Montreal.
Numinus R&D develops clinical and therapeutic protocols to use in treatments, in collaboration with research partners and regulators.
Numinus Bioscience develops formulations and methods for a safe supply, using Health Canada licences, scientific expertise and cutting-edge technology.
Learn more at numinus.ca, and follow us on Facebook, Twitter, and Instagram.
About MAPS
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $100 million for psychedelic therapy and medical marijuana research and education.
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization
This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.
About Ryan Allway
Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.
Search CannabisFN
Press Coverage
Psychedelics Index
Top Videos
The producers of O’ Cannabiz have decades of experience producing national-profile events and creating global connections between business communities in the arts, broadcasting, media and technology. They have organized trade summit initiatives with governments around the world. And they have worked closely with sponsors in all levels of Canadian government.
Watch CFN Media’s exclusive three part interview with Paul Rosen, one of the most active and diversified investors in the emerging cannabis industry. Paul gives his insights on the global cannabis industry and discusses his new endeavors. Become a CFN Media Client Paul Rosen is a noted career entrepreneur and management consultant. Over the last […]
IONIC BRANDS is a national cannabis holdings company based in Washington, led by a team of successful entrepreneurs.
Silo Pharma is a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as depression, PTSD, Parkinson’s, and other rare neurological disorders.
Network Partners
About CFN Media Group
CFN Enterprises Inc. (OTCQB: CNFN) owns and operates CFN Media Group, the premier agency and financial media network reaching executives, entrepreneurs and consumers worldwide. Through its proprietary content creation, video library, and distribution via www.CannabisFN.com, CFN has built an extensive database of cannabis interest, assisting many of the world’s largest cannabis firms and CBD brands to build awareness and thrive. For more information, please visit www.cfnenterprisesinc.com.
Disclaimer: Matters discussed on this website contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time-to-time have a position in the securities mentioned herein and will increase or decrease such positions without notice. The Information contains forward-looking statements, i.e. statements or discussions that constitute predictions, expectations, beliefs, plans, estimates, or projections as indicated by such words as "expects", "will", "anticipates", and "estimates"; therefore, you should proceed with extreme caution in relying upon such statements and conduct a full investigation of the Information and the Profiled Issuer as well as any such forward-looking statements. Any forward looking statements we make in the Information are limited to the time period in which they are made, and we do not undertake to update forward looking statements that may change at any time; The Information is presented only as a brief "snapshot" of the Profiled Issuer and should only be used, at most, and if at all, as a starting point for you to conduct a thorough investigation of the Profiled Issuer and its securities and to consult your financial, legal or other adviser(s) and avail yourself of the filings and information that may be accessed at www.sec.gov, www.pinksheets.com, www.otcmarkets.com or other electronic sources, including: (a) reviewing SEC periodic reports (Forms 10-Q and 10-K), reports of material events (Form 8-K), insider reports (Forms 3, 4, 5 and Schedule 13D); (b) reviewing Information and Disclosure Statements and unaudited financial reports filed with the Pink Sheets or www.otcmarkets.com; (c) obtaining and reviewing publicly available information contained in commonlyknown search engines such as Google; and (d) consulting investment guides at www.sec.gov and www.finra.com. You should always be cognizant that the Profiled Issuers may not be current in their reporting obligations with the SEC and OTCMarkets and/or have negative signs at www.otcmarkets.com (See section below titled "Risks Related to the Profiled Issuers, which provides additional information pertaining thereto). For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity-based compensation in the companies it writes about, or a combination of the two. For full disclosure, please visit: https://www.cannabisfn.com/legal-disclaimer/. A short time after we acquire the securities of the foregoing company, we may publish the (favorable) information about the issuer referenced above advising others, including you, to purchase; and while doing so, we may sell the securities we acquired. In addition, a third-party shareholder compensating us may sell his or her shares of the issuer while we are publishing favorable information about the issuer. Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two. For full disclosure please visit: https://www.cannabisfn.com/legal-disclaimer/.
Copyright © Accelerize Inc. · All Rights Reserved · Privacy Policy · Legal Disclaimer
