Emyria’s Specialist Psychiatrist Granted Authorised Prescriber Status in MDMA-Assisted Therapy for PTSD

Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) focused on delivering and developing new treatments for mental health and select neurological conditions, is pleased to announce the Company’s distinguished 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 ¹ and within the strict regulatory framework established by the TGA for the treatment of Post-Traumatic Stress Disorder (PTSD). ²

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HIGHLIGHTS

• Emyria's key specialist has been granted "Authorised Prescriber" approval from the TGA
• Authorisation reflects Emyria's dedication to mental health care under strict regulatory, ethical, and safety standards
• Achieving Authorised Prescriber status for MDMA-assisted therapy in PTSD care signifies a strategic step towards expanding Emyria's service offerings

Dr. Michael Winlo, CEO and MD, 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 capacity for impactful and responsible growth in the field of mental health treatments."

Initial focus on Post-Traumatic Stress Disorder (PTSD):

PTSD affects approximately 1 million Australians ³. With up to one third of patients failing to benefit from conventional therapies, there is a growing need for more effective treatments. 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. ^{4, 5}

Emyria is currently studying MDMA-AT therapy for PTSD in an ethics-approved clinical trial (EMDMA-001). Experience with the trial has informed a unique delivery model for Emyria’s Authorised Prescriber program.

Authorised Prescribers must adhere to stringent TGA guidelines to ensure the highest level of patient care and safety. The authorisation is part of Emyria’s broader commitment to increasing options for mental health through robust clinical research and ethical practice.

A presentation explaining how the Authorised Prescriber milestone fits into Emyria’s broader strategy will be available on the ASX platform.

Risks associated with the use of MDMA

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 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.

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This article includes content from Emyria Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

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