Emyria Ltd (ASX:EMD) has received Human Research Ethics Committee (HREC) approval to conduct its ground-breaking MDMA-assisted clinical therapy for patients with Post-Traumatic Stress Disorder (PTSD).
The trial, known as EMDMA-001, will be a 12-month, open-label study conducted in partnership with PAX Centre, one of Australia’s leading trauma-focused, multi-disciplinary psychiatric services specialising in the treatment of complex trauma.
In Australia, about 1 million people suffer from PTSD, of which 30-50% of patients have an ineffective response or resistance to standard therapies, while in the US, about 10 million people suffer from PTSD, resulting in about US$232.2 billion in economic burden costs per year.
Commitment to care
“We're excited to announce the recent ethics approval for Emyria’s MDMA-assisted therapy trial for PTSD,” Emyria managing director Dr Michael Winlo said.
“This pivotal step, made possible by our partnership with The Pax Centre, highlights our commitment to advancing new psychiatric care.
“Our joint endeavour aims to deliver a safe, cost-effective and scientifically-grounded approach to PTSD treatment that can support the development of cost-effective and scalable MDMA-assisted therapy delivery in the community.
“This trial is expected to improve patient outcomes in a safe environment and generate valuable Real World Data, allowing program improvements and furthering Emyria’s drug analogue development.
“For our investors and shareholders, this represents a significant milestone and growth opportunity in the burgeoning field of psychedelic-assisted therapy.”
New patient access
MDMA-assisted therapy has shown promising results in treating PTSD but its use has been limited to research settings with strict protocols until now.
Beginning July 1, Australia’s Therapeutic Goods Administration (TGA) has reclassified MDMA-assisted therapy as a Schedule 8 controlled medicine, which means that patients will have access to the therapy through prescription from specialist psychiatrists who have obtained Authorised Prescriber status.
To support this new era of patient access, Emyria has developed a licensable package that includes an ethics-approved care model and a reliable drug supply to assist psychiatrists within its network to obtain Authorised Prescriber status.
So far, 20 psychiatrists, GPs, mental health nurses, clinical psychologists and counsellors have completed their therapist training led by renowned psychiatrist and psychedelic-assisted therapy researcher Dr Ben Sessa.
The clinical data generated from the EMDMA-001 trial will support ongoing improvements in care models, cost-effectiveness studies for reimbursement purposes and Emyria's MDMA-inspired drug development program in collaboration with the University of Western Australia.