Emyria Ltd (ASX:EMD) is a step closer to becoming an Authorised Prescriber (AP) of MDMA for MDMA-assisted therapy applications, having secured an endorsement from the National Health and Medical Research Council (NHMRC) accredited ethics committee.
The approval clears the first stage of a 2-step evaluation to become an authorised prescriber of Schedule 8 substances, a category MDMA and psilocybin occupy for PTSD and treatment-resistant depression, respectively.
The next step will require final approval from the Therapeutic Goods Administration (TGA), the application for which is already in progress.
Offering new options for patients
“The AP program provides new, but unapproved, options for patients who have exhausted standard care options,” Emyria managing director Dr Michael Winlo said.
“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.”
Emyria sees the need for beneficial and durable PTSD treatments as a pressing concern in Australia, where around 1 million people are affected by the disorder.
The company is investing in capability to deliver emerging, promising treatments such as MDMA-AT for PTSD, which has shown promising clinical results in multiple Phase 3 trials by MAPS in the US and is emerging as a potential new treatment approach.
Should EMD receive the final AP approvals from the TGA, the company will be positioned as one of the first Australian groups to offer broader options for PTSD patients with inadequate relief from conventional care.