Emyria Ltd (ASX:EMD) has secured all requisite permits from Health Canada to begin the importation into Australia of its patient-ready supply of MDMA, finalising a pivotal regulatory pathway.
This development closely follows the initiation of active dosing in the company's ethics-approved MDMA-assisted therapy (MDMA-AT) trial, marking a significant milestone for private specialist clinics in Australia.
Having previously received approval from Australia's Office of Drug Control (ODC), the latest Health Canada authorisation allows Emyria to import sufficient MDMA to support up to 70 patients.
The initial target indication is Post-Traumatic Stress Disorder (PTSD), a condition affecting roughly 1 million Australians.
"Significant milestone"
Emyria CEO Dr Michael Winlo said: "As a leading private specialist clinic in Australia, we've achieved a significant milestone with the initiation of active MDMA-assisted therapy.
"Our initial MDMA supply for up to 70 patients, combined with our steady progress towards Authorised Prescriber status, underscores our commitment to exploring promising treatments for PTSD sufferers and elevating mental health care outcomes in Australia."
For use in trial
Emyria's MDMA supply is earmarked for its active MDMA-AT trial, known as EMDMA-001, and could extend to direct patient care pending authorised prescriber (AP) status approval from the Therapeutic Goods Administration (TGA).
Current AP applications are under ethics committee review, requiring subsequent TGA consent.
The EMDMA-001 trial serves as the foundation for Emyria's AP offering for MDMA-AT by equipping Emyria’s clinical staff with an ethics-approved protocol and preparing the team for the AP program's stringent requirements.
Real-world data and insights
The EMDMA-001 trial aims to generate real-world data and insights that could guide Emyria's planned AP program and inform commercial scalability.
It also intends to strengthen Emyria’s AP application and provide robust clinical evidence to engage payers.
This comes as MDMA-AT has demonstrated high efficacy and safety in second Phase 3 clinical trials conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS) in the United States.
With a focus on PTSD treatment, this advancement positions Emyria at the forefront of ethical and commercial viability in MDMA-assisted therapeutic approaches.