Mental health treatment provider Emyria (ASX: EMD) has announced that its psychiatry specialist has been granted “Authorised Prescriber” status by the Therapeutic Goods Administration (TGA).
The authorisation enables the prescribing of MDMA according to an ethics committee endorsed care model developed by Emyria and within the strict regulatory framework established by the TGA for the treatment of Post-Traumatic Stress Disorder (PTSD).
Achieving this status for MDMA-assisted therapy in PTSD care signifies a strategic step towards expanding Emyria’s service offerings.
CEO and MD Dr. Michael Winlo commented, “This authorisation demonstrates Emyria’s commitment to evaluating emerging treatments within the strict regulatory framework set by the TGA. Emyria’s expertise and track record in innovative clinical service development and Real-World Data capture uniquely positions us to evaluate new therapeutic options in a safe and responsible way. Achieving Authorised Prescriber status showcases Emyria’s cap.”
PTSD impacts around 1 million Australians, and with up to one third of patients not responding well to standard treatments, there’s a rising demand for more effective solutions.
Emyria is investigating the use of MDMA-assisted therapy (MDMA-AT) as a possible PTSD treatment, gaining insights from Phase 3 clinical trials by MAPS in the USA. MDMA-assisted therapy (MDMA-AT) is believed to help patients explore traumatic memories with less distress. Enhanced feelings of trust and well-being during MDMA’s influence can facilitate communication and bolster the therapeutic bond between the patient and therapist.
In two separate Phase 3 trials, 70% of participants no longer met PTSD criteria after three treatments, a significant improvement compared to the placebo group (~48%). Additionally, MDMA proves cost-effective, with an expected savings of $199 million over 30 years per 1,000 treatments.
Currently, Emyria is conducting an ethics-approved clinical trial (EMDMA-001) for MDMA-AT therapy in PTSD. Insights from this trial have shaped a distinctive delivery model for Emyria’s Authorised Prescriber program.
Emyria’s Non-Executive Chairman Greg Hutchinson added, “With approved Authorised Prescribers, Emyria is advancing from trials to treatment which we believe is a world-first for a community-based service.”
In Australia, 15% of adults reported experiencing “high” to “very high” mental distress in the past 12 months. At the same time, one in five have had a mental health disorder. Making matters worse, over a million Australians are unable to access care due to workforce shortages of trained mental health professionals.
Authorised Prescribers must follow strict TGA guidelines to uphold the highest standards of patient care and safety. This authorisation reflects Emyria’s broader dedication to expanding mental health options through rigorous clinical research and ethical practices.
Looking to 2024, Emyria aims to expand nationally and perhaps even explore mental health conditions beyond PTSD, starting with depression. It also wants to lock in some major partnerships to boost its growth avenues.
Emyria is also developing MDMA-inspired medicines with the University of Western Australia, including its drug candidate EMD-MX1, a faster acting MDMA with improved side effects.
Alinda is a Business Reporter for The Sentiment
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