Optimi Health Congratulates Lykos Therapeutics on FDA Priority Review of New Drug Application And Releases MDMA Production Video
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:
michaelk@optimihealth.ca
902.880.6121
For investor inquiries, please contact:
investors@optimihealth.ca
www.optimihealth.ca
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
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.
FORWARD‐LOOKING STATEMENTS
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 https://www.globenewswire.com/NewsRoom/AttachmentNg/e527545e-00aa-4bf9-92e7-aa758a645e3a
