Emyria Ltd (ASX:EMD)'s specialist psychiatrist has been granted Authorised Prescriber approval from the Therapeutic Goods Administration (TGA) for MDMA-assisted therapy in post-traumatic stress disorder (PTSD) care.
The company is developing new treatments for mental health and select neurological conditions, and the new status will enable Emyria to expand its service offerings.
Authority to prescribe
Emyria is now able to prescribe MDMA according to an ethics committee-endorsed care model developed by the company within the strict regulatory framework established by the TGA for the treatment of PTSD.
There is a growing need for more effective treatments for PTSD, and the company is hoping to step into this breach.
In Australia, one million people are affected by the condition and up to one-third of patients fail to benefit from conventional therapies.
MDMA-assisted therapy (MDMA-AT) is being evaluated as a treatment for PTSD and multiple Phase 3 clinical trials have been conducted by MAPS in the USA.
Emyria is currently studying MDMA-AT therapy for PTSD in an ethics-approved clinical trial.
Experience with the trial has informed a unique delivery model for Emyria’s Authorised Prescriber program.
The authorisation is part of Emyria’s broader commitment to increasing options for mental health through robust clinical research and ethical practice and confirms Emyria's dedication to mental health care under strict regulatory, ethical and safety standards.
Stringent regulations governing MDMA
Authorised prescribers must adhere to stringent TGA guidelines to ensure the highest level of patient care and safety.
All medicines carry risks and specialist prescribers, such as registered psychiatrists, are best placed to assess the suitability of a new medication against a patient’s individual circumstances and medical history before proceeding.
Adverse effects of MDMA can include high blood pressure, increased pulse rate, faintness and panic attacks, and in some rare cases, it can cause loss of consciousness or trigger seizures.
Other side effects include involuntary jaw clenching, decreased appetite, restless legs, nausea, headache, sweating and muscle/joint stiffness.
These effects are unlikely at low doses in the treatment regimens used in psychedelic-assisted psychotherapy while appropriately managed in a controlled environment with direct medical supervision.
Expertise and proven track record
"This authorisation demonstrates Emyria’s commitment to evaluating emerging treatments within the strict regulatory framework set by the TGA,” CEO and managing director Dr Michael Winlo said.
“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 capacity for impactful and responsible growth in the field of mental health treatments."
A presentation explaining how the Authorised Prescriber milestone fits into Emyria’s broader strategy will be available on the company’s ASX platform.
Emyria shares have been as much as 23.73% higher intraday to $0.073.