20:15:57 EDT Mon 17 Jun 2024
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Optimi Health Corp
Symbol OPTI
Shares Issued 87,227,566
Close 2024-02-12 C$ 0.34
Market Cap C$ 29,657,372
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Optimi Health releases MDMA production video

2024-02-12 10:06 ET - News Release

Mr. Bill Ciprick reports


Optimi Health Corp. extends its congratulations to Lykos Therapeutics (formerly MAPS Public Benefit Corp.) on the recent acknowledgment 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 good manufacturing practice 3,4-methylenedioxymethamphetamine encapsulation and production process.

Lykos Therapeutics has been at the forefront of revolutionizing mental health care, and this milestone achievement further demonstrates its dedication to addressing the critical needs of individuals suffering from posttraumatic stress disorder. 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, chief executive officer 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, licences and ensuring an effective quality management system."

The Prescription Drug User Fee Act (PDUFA) target action date for the application is set for Aug. 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 40-milligram and 60 mg 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 new drug application.

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.

Mr. 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.

About Optimi Health Corp.

Optimi Health is 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 No. 1 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, B.C.

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