Optimi Health Receives Regulatory Approval to Export to Australia

Health Canada awarded a drug-establishment license to the Vancouver-based manufacturer of psychedelic pharmaceuticals.

Health Canada has awarded a drug-establishment license to Optimi Health Corp. for the manufacturing and sale of its MDMA and psilocybin capsules, according to the company.

In a letter to shareholders, Optimi co-founder and Chairman JJ Wilson called the designation “a significant milestone in our efforts to build a robust, GMP-compliant company capable of supplying MDMA and psilocybin capsules to regulated markets.”

“This license, a requirement set forth by Health Canada, now allows us to ship both MDMA and psilocybin capsules as treatment options to Australia to help patients suffering from PTSD and treatment-resistant depression,” Wilson added.

Psychiatrists in Australia who are authorized by the Therapeutic Goods Administration can request the importation of Optimi’s MDMA and psilocybin capsules for use in patients, the company noted. The pre-authorized Australian Psychiatrist Portal is expected to launch on June 24 to approximately 2,800 psychiatrists.

Optimi recently received an import certificate to supply 160 doses of MDMA and psilocybin to fulfill initial patient prescriptions by Mind Medicine Australia, according to the company.

“It has been imperative for us to deliver on our promise to build the necessary infrastructure, obtain the required licenses and develop our business to be ready to participate in the global psychedelics market,” Wilson explained in the letter to shareholders. “Optimi possesses capabilities that very few companies in the world have: the ability to commercialize our pharmaceutical-grade psychedelics, starting with Australia.”

The company said it now is focusing on the registration of both drugs with the U.S. Food and Drug Administration through the implementation of mutual recognition agreements.