Optimi Health (CSE:OPTI; OTCQX:OPTHF; FSE:8BN) reports completion of its inaugural export of GMP-validated, 3,4-methylenedioxymethamphetamine (MDMA) capsules to Australia for the treatment of patients with post-traumatic stress disorder (PTSD).
The first cohort of patients is scheduled to begin MDMA-assisted therapy in the coming weeks. Optimi aims to gather critical real-world evidence and patient-reported outcomes for MDMA-assisted therapy in Australian PTSD patients.
The export follows the recent acquisition of Optimi’s Drug Establishment Licence, a requirement for supplying MDMA capsules to patients in clinical settings worldwide, and was completed in partnership with Mind Medicine Australia.
Moreover, Optimi has secured an export permit from Health Canada for its first GMP-validated natural psilocybin extract shipment to the Matai Medical Research Institute in New Zealand. This shipment will support a pilot study on the feasibility, acceptability, and safety of psychedelic-assisted therapy in healthy volunteers, with insights guiding future trials for Maori patients with methamphetamine use disorder.