Shares in Emyria and Little Green Pharma have spiked following a decision by the Therapeutic Goods Administration (TGA) to improve patient access to psilocybin and MDMA.
Emyria saw a 55% lift to $0.31c in yesterday’s trading, while LGP also rallied, with shares rising 43% to $0.265c.
From July 1, the TGA will allow approved psychiatrists to prescribe psilocybin and MDMA for treatment-resistant depression and post-traumatic stress disorder.
The TGA said they are the only conditions where there is “sufficient evidence for potential benefits in certain patients.” For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard.
For all other uses, they will remain in Schedule 9 (Prohibited Substances), which largely restricts their supply to clinical trials.
Psychiatrists will need to be approved under the Authorised Prescriber scheme to write scripts.
Emyria immediately said it would expand its MDMA program.
“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,” chief executive Dr Michael Winlo said.
“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.
“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.”
He said Emyria has already developed a comprehensive MDMA-assisted therapy protocol “that can now support specialists”, while it has also created a MDMA-inspired drug-discovery program in partnership with the University of Western Australia.
Shaun Duffy, chief executive of LGP subsidiary Reset Mind Sciences, said: “The announcement by the TGA is truly groundbreaking in the field of psychedelics and I welcome their decision.
“There is a significant body of research emerging in Australia and globally for the use of psychedelics to treat mental health conditions and this decision allows the use of these drugs for the mental health conditions that have demonstrated the most potential in the research.”
Reset Mind Sciences said it is in the “advanced stages” of preparations for a Perth-based clinical trial using psilocybin for treatment-resistant depression.
Advocacy group Mind Medicine Australia, which lodged a bid to down schedule psilocybin and MDMA in July 2020 – and again in March 2022 after the earlier application was rejected – thanked the “enormous number of Australians who lodged their submissions in support”.
“We are delighted with the decision which will be welcomed by so many suffering Australians,” it said. “It specifically recognises the current lack of options for patients with specific treatment-resistant mental illnesses and the supporting evidence of safety and efficacy from clinical trials.
“The support that we have had throughout this process has been incredible and overwhelming.
The Royal Australian and New Zealand College of Psychiatrists also cautiously welcomed the move. President associate professor Vinay Lakra told The Guardian: “We need to take some baby steps rather than one giant leap.
“So this is a baby step in the right direction and what it does is allow us to do things in an appropriately safe way for everyone… and if necessary take a step back as well.”