- The Australian government has announced a $15 million grant round for clinical trials exploring the use of breakthrough combination therapies to treat mental illnesses.
- Australian trials assessing the safety and efficacy of psychedelic drugs including ketamine, psilocybin, and MDMA as treatment options are eligible to apply for funding.
- However, the country continues to block the use of psilocybin and MDMA for psychedelic-assisted therapy, with a final decision on the status of these drugs to be handed down by the Therapeutic Goods Administration on April 22.
The Australian government has launched a $15 million grant round for Australian clinical trials exploring the use of potential breakthrough combination therapies for the treatment of mental illnesses. Funding for the Innovative Therapies for Mental Illness Grant Opportunity under the Medical Research Future Fund (MRFF) will be available over three years from 2021-22 for a total duration of project activity up to five years.
Announcing the grant round on March 17, the government said standard treatments for mental health illnesses had varied efficacy and recovery rates, and there had been few advances in novel pharmaceutical discoveries in recent years. “However, there is now a strong and emerging body of international evidence that shows that substances such as ketamine, psilocybin, and MDMA, when used in a controlled environment and supported by psychological/psychiatric care, offer a promising new approach to effectively treating pernicious mental illnesses that are resistant to first-line treatments,” the government said in a statement. “Several have been granted ‘breakthrough therapy’ status for the treatment of post-traumatic stress disorder (PTSD) and major depressive disorder by the United States Food and Drug Administration (FDA).”
Minister for Health and Aged Care Greg Hunt said the MRFF would ensure Australia’s medical research sector stayed at the forefront of global innovation. “The early results of trials in Australia and internationally are extremely encouraging, but more research is desperately needed before these approaches can be used by psychiatrists outside of controlled clinical trials,” he said. “It is vital that we continue to support the search for new and better treatments for mental illness. This grant opportunity will boost local research into potentially life-saving therapies and offers hope to all those suffering from mental illness, including our veterans and emergency service personnel dealing with the devastating effects of PTSD.”
Funding Welcome but Access Issues Remain, says Mind Medicine Australia
Mental health charity Mind Medicine Australia welcomed the funding announcement but said more needed to be done to provide much-needed access to psychedelic therapies. In a statement, the charity’s chairman Peter Hunt said: “we also urgently need the medical use of psilocybin as part of therapy for treatment-resistant depression and the medical use of MDMA as part of therapy for treatment-resistant PTSD to be rescheduled from Schedule 9 of the Poisons Standard (Prohibited Substances) to Schedule 8 (Controlled Medicines).”
In July 2020 Mind Medicine Australia applied to the Therapeutic Goods Administration for these medicines to be rescheduled. But in an interim decision on the application published on February 3, the TGA said the current classifications of both psilocybin and MDMA as prohibited substances remained appropriate. Mind Medicine Australia has made a submission to the TGA opposing the interim decision on scientific and humanitarian grounds, and a final decision will be handed down on April 22.
“These medicines have been shown in overseas trials to be safe and non-addicted when used in medically controlled environments and are achieving very high remission rates,” Peter Hunt said. “They should be available for use in our medical system across Australia with TGA approval on a case-by-case basis.”
Mind Medicine executive director Tania de Jong added that the current approval process for psychiatrists to gain permission from the TGA to use psychedelic medicines as part of psychotherapy in a medically controlled environment was absurd. “This absurd situation means an enormous amount of unnecessary suffering for people with treatment-resistant depression and treatment-resistant PTSD,” de Jong said. “There is plenty of safety and efficacy data from overseas trials to support the rescheduling and their use in Australia on a case-by-case basis as occurs in other jurisdictions such as Canada, the United States, Israel, and Switzerland.”