Emyria Ltd (ASX:EMD) has inked an agreement with Canadian manufacturer PharmAla for the supply of clinical-grade MDMA, facilitated by Mind Medicine Australia, to support MDMA-assisted trials once the Therapeutic Goods Administration (TGA) reschedules MDMA and psilocybin to Schedule 8 (Controlled Drugs) on July 1, 2023.
The company is working to build a network of research-oriented therapists and psychiatrists, supporting the preparation of sites and care teams to provide MDMA-assisted therapy to appropriately diagnosed patients.
Working with reputable providers
“Emyria has expertise delivering treatments to patients with substances listed under Schedule 8 and 9 while generating Real-World Evidence to support care model improvement and novel drug development,” Emyria managing director Dr Michael Winlo said.
“To support its partners to provide MDMA-assisted therapy from July 1, Emyria has secured a short-term supply of patient-ready MDMA that can be provided within a comprehensive care model (EMDMA-001) together with appropriately trained and reputable care providers.
“Our approach of participating in care delivery also supports our analogue program.”
Until the reschedule, the use of MDMA was restricted to clinical trials. With the reduced restrictions around a Schedule 8 drug, Emyria will be able to supply MDMA to partner psychiatrists with Authorised Prescriber status or under ethics-approved clinical trials.
Australia will be one of the first countries to allow patients to access these MDMA-assisted therapies, offering a first-mover advantage to the companies positioned to capitalise.
