Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN) has welcomed final recommendations from Australia's Therapeutic Goods Administration (TGA) regarding its Authorized Prescriber scheme for psilocybin and MDMA. The updated framework, which broadens eligible therapy teams and expands treatment settings beyond hospital environments, is expected to support the scaling of psychedelic-assisted therapy across Australia.
Under the revised framework, authorized psychiatrists can prescribe Optimi's GMP-compliant MDMA for post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression. The company noted that the changes could accelerate adoption of psychedelic-assisted therapy by increasing workforce capacity, particularly in rural and regional areas, while also expanding reimbursement opportunities across both public and private payers.
Optimi also highlighted that no serious adverse events have been reported under Australia's regulated commercial psychedelic treatment program since December 2025, supporting continued expansion of what the company describes as the world's most advanced commercial market for prescribed psilocybin and MDMA therapies.
This development is significant for the mental health treatment landscape, as Australia continues to refine its regulatory approach to psychedelic-assisted therapies. The expanded framework may enable more patients to access these treatments, especially in underserved areas, and could set a precedent for other countries considering similar regulatory updates.
For more information, visit Optimi Health Corp.
