Health Canada Approves Optimi Health Precursor License to Formulate MDMA and Encapsulate Various Dosages

In a recent press release, Optimi Health, “a Health Canada licensed drug researcher and formulator specializing in controlled psychedelic substances such as natural psilocybin and MDMA,” (1) announced that they received a Precursor License for 3,4-Methylenedioxyphenyl-2-propanone (MDP2P) from Health Canada. This chemical compound is the predecessor to 3,4-Methyl​enedioxy​methamphetamine (MDMA) (1).

Optimi Health gained their Precursor License back in December 2023 (1) through Section 16 of the Precursor Control Regulations. This access provides the drug researcher to “import MDP2P for the purpose of formulating and verifying MDMA drug candidates” at the their research and analytical facility located in Princeton, British Columbia, Canada (1). Health Canada had also toured the establishment recently.

“Securing our precursor licence represents a pivotal advantage for Optimi, offering a compelling edge in producing MDMA at significantly reduced costs,” Jacob Safarik, Optimi Chief Financial Officer, commented (1). “This strategic move aligns with our intent to address market demand for GMP MDMA in 2024, especially amid the heightened anticipation surrounding the recent New Drug Application (NDA) submission by the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC) to the U.S Food and Drug Administration (FDA).”

The Chief Financial Officer also mentioned a recent update stemming from the American Medical Association (1), “With the AMA’s current procedural terminology ("CPT") III codes for psychedelic-assisted therapies now officially in effect, this underscores the goal of obtaining our precursor license. With potential FDA approval, physicians and other qualified healthcare providers seeking coverage and reimbursement for delivering psychedelic-assisted therapy will now have a reliable partner who can formulate and encapsulate the most cost-effective, high-quality, and accessible MDMA solutions in the market.”

After obtaining the Precursor License, Optimi Health was able to encapsulate MDMA into two dosage formats, 40mg and 60mg (1). “This milestone is more than formulation. It symbolizes our dedication to achieving scientific uniqueness in alliance with industry pioneers such as the MAPS PBC who are paving the road ahead,” Dr. Preston A. Chase said (1). “Our innovation journey is grounded in advancing the safety and validity of our MDMA drug candidate, and I am happy to say that we’re just hitting our stride in becoming the premier provider of fully verified, encapsulated MDMA in 2024 and beyond.”

In one of the last developments Optimi Health disclosed in their press release (1) is that they are working on being granted a Certificate of Analysis (COA) from a third-party laboratory which will help provide their clients with further assurance.

Reference

1. Optimi Health Corp. Optimi Health Granted Precursor Licence To Formulate MDMA And Completes Encapsulation Of 40mg And 60mg Dosage Formats https://www.globenewswire.com/news-release/2024/01/03/2803195/0/en/Optimi-Health-Granted-Precursor-Licence-To-Formulate-MDMA-And-Completes-Encapsulation-Of-40mg-And-60mg-Dosage-Formats.html (accessed Jan 3, 2024).