Emyria secures ethics endorsement for MDMA authorised prescriber application

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Emyria (ASX:EMD) has announced that its lead psychiatrists have received endorsement from an NHMRC-accredited ethics committee, allowing them to advance their authorised prescriber applications with the TGA.

The TGA recently rescheduled MDMA and psilocybin for Post-Traumatic Stress Disorder and treatment-resistant depression. The restricted prescribing remains highly stringent due to the lack of 'approved' or 'registered' versions of these medicines.

They can only be accessed via clinical trials or from specialist psychiatrists who secure approved prescriber status from the TGA.

The requirements for becoming an authorised prescriber mandate that applying specialists first achieve endorsement from either an NHMRC-accredited ethics committee or the Royal Australian and New Zealand College of Psychiatrists (‘RANZCP’).

With ethics committee endorsement, Emyria said it can now progress its authorised prescriber (AP) applications with the TGA.

Emyria managing director Dr Michael Winlo said, “The AP program provides new, but unapproved, options for patients who have exhausted standard care options. With our history of successfully securing over 16 AP approvals for our clinicians involved in our cannabinoid treatment programs, this ethics committee endorsement further highlights our dedication to expanding care options for Australian patients.”