Emyria (ASX:EMD) says it is “well positioned” to accelerate patient access to psychedelic substances following the TGA’s decision to reclassify psilocybin and MDMA from 1 July this year.
The decision means the two substances can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions.
Emyria said it is adapting an existing clinical trial protocol so that specialist psychiatrists can meet the requirements for authorised prescriber status.
This process requires an evaluation by a Human Research Ethics Committee. Emyria said that its clinical subsidiary has successfully applied for 16 Authorised Prescriber determinations relating to the provision of unregistered cannabinoid medicines to patients with unmet needs.
“This protocol can now be adapted to support specialist psychiatrists meet the requirements for Authorised Prescriber status,” it said. “Preclinical studies are currently underway to identify candidates for next-generation MDMA-assisted therapy, and treatments for other major neurological conditions, creating a robust and unique preclinical research and development pipeline.”
According to Emyria’s managing director Dr Michael Winlo, “The mental health crisis – in Australia and around the world – continues to have untold cost, which is why the TGA’s move to reschedule MDMA and psilocybin is timely and world-leading.
“Emyria is well-prepared to support the safe provision of MDMA-assisted therapies under this new change as the only ASX company with a clinical service specialising in unregistered medicines and Real-World Data generation. Emyria has also developed a comprehensive MDMA-assisted therapy protocol that can now support specialists.
“Further, Emyria is also leading a wave of future innovation via our active MDMA-inspired drug discovery program in partnership with the University of Western Australia.
We believe the TGA’s decision will allow Emyria – and its partners – to build a stronger evidence base for treating mental health conditions with psychedelics and make a large and positive impact for patients globally.”