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

Optimi Health Corp.

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.

/Public Release.