Skip to content
Medical Health Aged Care

Optimi Health Congratulates Lykos Therapeutics on FDA Priority Review of New Drug Application And Releases MDMA Production Video

Optimi Health Corp. 4 mins read

Company shares behind-the-scenes look at its GMP MDMA encapsulation and production process

VANCOUVER, British Columbia, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a Health Canada licensed drug researcher and formulator specializing in controlled psychedelic substances such as natural psilocybin and MDMA, extends its congratulations to Lykos Therapeutics (formerly MAPS Public Benefit Corporation) on the recent announcement of the U.S. Food and Drug Administration's (FDA) acceptance and priority review of its new drug application (NDA). Additionally, Optimi is pleased to unveil a six-minute video showcasing its end-to-end GMP MDMA encapsulation and production process.

Lykos Therapeutics has been at the forefront of revolutionizing mental healthcare, and this milestone achievement further demonstrates their dedication to addressing the critical needs of individuals suffering from PTSD. The FDA's priority review designation underscores the significance of this potential breakthrough in providing effective treatment options for those impacted by this debilitating condition.

Bill Ciprick, CEO of Optimi Health, stated, "We commend Lykos Therapeutics and MAPS founder, Rick Doblin, for their unwavering dedication to advancing innovative therapies for PTSD. This milestone marks a monumental leap forward in therapeutic research, providing much-needed solutions to those in dire need. Moreover, we are seizing this momentous occasion to reaffirm our commitment to emerge as the foremost supplier of GMP MDMA, leveraging our exceptional infrastructure, licenses, and ensuring an effective quality management system.”

The Prescription Drug User Fee Act (PDUFA) target action date for the application is set for August 11, 2024. Pending approval, this therapy would mark a historic milestone as the first MDMA-assisted therapy and psychedelic-assisted therapy for PTSD.

In January, Optimi Chief Science Officer, Dr. Preston A. Chase, reported the successful encapsulation of MDMA into 40mg and 60mg dosage formats after verification through its High-performance Liquid Chromatography (HPLC) methodology. He added that the milestone further aligns Optimi strategically with the Lykos published protocol and recent NDA.

Optimi GMP MDMA Quality Assurance Video Release:

Dane Stevens, Co-founder and Chief Marketing Officer at Optimi, today unveiled the Company’s latest educational video designed to provide frontline researchers, academics, and clinicians pioneering the future of psychedelic therapy with a deeper understanding of the GMP manufacturing processes behind the Company’s drug candidates. The six-minute video demonstrates Optimi's commitment to quality assurance and provides stakeholders with valuable insight into how the company plans to deliver its products safely and at scale.

Stevens stated, "The ability to showcase our GMP MDMA production process is a testament to our commitment to excellence and transparency. It underscores our dedication to providing high-quality, standardized products that meet stringent regulations and ensures the safety, quality, and purity of our offerings."

The video can be viewed on the Company’s YouTube channel.

For media inquiries, please contact Michael Kydd:

For investor inquiries, please contact:


Optimi Health Corp. an end-to-end drug researcher and formulator licensed by Health Canada to produce and supply, for clinical research purposes, psychedelic substances such as 3,4-Methylenedioxymethamphetamine (“MDMA”), natural GMP-grade psilocybin, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe drug candidates throughout the world. Optimi’s products are grown and manufactured at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.


This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, “forward-looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward-looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. forward-looking statements made in this news release include the proposed use of the proceeds of the Offering. No assurance can be given that these expectations will prove to be correct and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.

Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Optimi undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

A photo accompanying this announcement is available at


Primary Logo

More from this category

  • Medical Health Aged Care
  • 24/02/2024
  • 07:07
CGFNS International

CGFNS International Unveils New Think Tank to Advance Health Workforce Development Scholarship and Solutions Worldwide?

PHILADELPHIA, PA / ACCESSWIRE / February 23, 2024 / CGFNS International announced today it has established a Global Health Workforce Development Institute. The new think tank will conduct original research and leverage knowledge developed by CGFNS over its half-century of providing credentialing services -- as well as its vast experience with workforce mobility issues -- to advance scientific knowledge about the evolution of health workforce roles and the development of credentialing and certification programs and policies.CGFNS International A long-term objective of the Institute will be to create rigorous global certification programs that streamline the assessment and recognition of practice competency.…

  • Medical Health Aged Care
  • 24/02/2024
  • 02:52
Tilray Brands, Inc.

Tilray Medical Applauds German Bundestag and Landmark Passage of Medical Cannabis Act in Germany

New Medical Cannabis Act in Germany Provides Easier Access to Medical Cannabis for Patients Through the MedCanGCOLOGNE, Germany and NEUMÜNSTER, Germany, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Tilray Brands, Inc. (“Tilray”) (Nasdaq: TLRY; TSX: TLRY), a global leader in cannabis research, cultivation, production, and distribution, today announced that its medical cannabis division, Tilray Medical, the global leader in medical cannabis, enthusiastically welcomes the opening of the German medical cannabis market and the positive paradigm shift in German drug policy. Today’s landmark passage of the German Medical Cannabis Act represents a significant step forward and puts public health in the spotlight…

  • Medical Health Aged Care
  • 23/02/2024
  • 17:25
Royal Australian College of GPs

RACGP appoints new CEO

Georgina van de Water has been appointed as the new Chief Executive Officer of the Royal Australian College of GPs (RACGP). Ms van de…

  • Contains:

Media Outreach made fast, easy, simple.

Feature your press release on Medianet's News Hub every time you distribute with Medianet. Pay per release or save with a subscription.