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Australia reschedules psilocybin and MDMA

The decision “sets a new global standard for treatment with molecules like MDMA and Psilocybin”. 

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A brief history of psychedelics

In a groundbreaking development, Australia is to reclassify psilocybin and MDMA to enable prescribing by authorised psychiatrists. 

Under the new classification, the substances will change from Schedule 9 which is prohibited substances, to Schedule 8, which is controlled drugs, of the Poisons Standard. The change will take effect from 1 July, 2023. 

Under the new classification, Australia’s Therapeutic Goods Administration (TGA) will permit prescribing of MDMA for post-traumatic stress disorder (PTSD), and will permit prescribing of psilocybin for treatment-resistant depression.

Acknowledging the current lack of options for patients with specific treatment-resistant mental illnesses, the TGA has stated that these two conditions are the only ones for which there is currently sufficient evidence for potential benefits in certain patients.

How will it work?

According to a statement from the TGA, prescribing will be limited to psychiatrists “given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established”. 

It has also confirmed that any psychiatrists that want to prescribe these therapies will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.

Access to psychedelic therapies for Australians

The news has been welcomed by the industry in Australia, which has been pushing for a change in scheduling.

The decision was made following multiple applications to the TGA to reclassify the substances in the Poisons Standard, as well as public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling.

See also  Phase 1 trial to explore MDMA derivative in healthy volunteers

Australian-based psychedelics company, Mind Medicine Australia, made a statement saying: “We are delighted with the decision which will be welcomed by so many suffering Australians. 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.

“We want to express our enormous gratitude to the tens of thousands of people who have made this breakthrough possible including the TGA, the Delegate, the members of the TGA’s Medicines Scheduling Advisory Committee and all of the psychiatrists, psychologists, other mental health professionals, world-leading experts and all of the people who put in submissions of support.

“The support that we have had throughout this process has been incredible and overwhelming.

“Finally, our hearts go out to all those Australians suffering from treatment-resistant depression and treatment-resistant post-traumatic stress disorder. 

“They will now have the opportunity of accessing this breakthrough treatment with their mental health professionals, which has shown such positive safety and efficacy results internationally.”

PharmAla Biotech Holdings CEO, Nick Kadysh, stated: “This is a critically important announcement by the TGA, allowing for the direct prescription and treatment of patients with PTSD and Treatment-Resistant Depression with Psychedelic molecules.

“As the registered supplier to three different Australian clinical trials using MDMA – more than any other Psychedelics API supplier – PharmAla is the only company which has both GMP MDMA and Psilocybin in inventory, and stands ready to ship these molecules to Australia.”

COO of PharmAla Biotech, Dr Shane Morris, added: “The TGA decision absolutely sets a new global standard for treatment with molecules like MDMA and Psilocybin.

See also  DMT: nature's psychedelic

“Allowing specially-licensed psychiatrists to prescribe these molecules directly to patients is an excellent approach, and will certainly help drive other countries to re-assess how they regulate these molecules to meet patients’ medical needs.”

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Policy

UK advisory body issues rapid response on psychedelics for PTSD

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UK Government issues rapid response on psychedelic research

The UK’s independent Parliamentary Office of Science and Technology (POST) has issued a rapid response on psychedelic-assisted therapy for post traumatic stress disorder (PTSD).

The response is intended to inform policymakers on the topic as increasing research around psychedelics shows the compounds may hold promise as innovative treatments in the area of mental health.

The rapid response is the third response on psychedelics to come from POST – one of the first independent bodies of its kind in the world that sources independent analysis of public policy issues relating to science and tech for government.

Previous responses have covered depressive disorders, anxiety disorders and eating disorders.

See also  UK MPs demand answers as Drugs Minister dodges psilocybin debate

The response reads: “Research into the use of psychedelic-assisted psychotherapy for PTSD has been conducted using MDMA, ketamine, and the four ‘classical psychedelics’ (psilocybin, LSD, mescaline and DMT). These are described in POST’s rapid response article on depression.

“Generally, this approach involves ‘non-trip’ sessions with a medical professional to ensure safety, prepare the patient and build a relationship, and a minimum of one ‘trip’ session where the patient undergoes a form of talking therapy after administration of a psychedelic compound.

“Evidence from studies conducted in hundreds of participants suggests that psychedelic-assisted psychotherapy may be an effective treatment for PTSD. However, to date, there is not enough information from large clinical trials with sufficient participants comparing psychedelic-assisted psychotherapy directly to existing treatments.”

Responding to research and policy developments

POST’s responses on psychedelics have been issued following a parliamentary debate discussing psilocybin access in May 2023.

The debate saw a group of crossparty MPs call for the rescheduling of psilocybin to remove barriers to research and demand an urgent review of the evidence for psilocybin’s current status as a Schedule 1 drug under the Misuse of Drugs Regulations 2001, “with a view to rescheduling”.

The Royal College of Psychiatrists, psychedelic access non-profit Heroic Hearts UK, and other leading mental health charities, also wrote letters to the Veterans Minister and the Minister of State for Crime, Policing and Fire, urging them to champion access for patients in the UK.

The latest rapid response covers psychedelics for PTSD including Psychedelic-assisted psychotherapy for treating PTSD, MDMA, Ketamine, Classical Psychedelics and the Regulation of psychedelic drugs used in medicine.

Earlier this year, POST confirmed it intends to publish a major briefing on psychedelic drugs to treat mental health conditions in 2024.

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Policy

EMA workshop: One small step for Europe, one giant leap for psychedelics

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EMA workshop: One small step for Europe, one giant leap for psychedelics

In a watershed moment for psychedelics in Europe, the European Medicines Agency (EMA) held a workshop from 16 to 17 April to discuss regulatory guidelines for the development and therapeutic use of psychedelic medicines.

2024 is set to be an important year for psychedelics and the EMA multi-stakeholder workshop is just one of the key events kicking it into action.

The two-day workshop – Towards an EU Regulatory Framework – brought together patients, healthcare professionals, academia, regulators and industry.

As Europe risks lagging behind countries such as Australia and America in seizing the potential of psychedelics for mental health innovation, the meeting was held in response to a letter from a group of cross-party MEPs calling for the EU to act fast on these therapies.

See also  EMA adds psychedelics to major depression guidelines

The MEPs wrote to the EMA and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) to say the organizations need to play a more active role in the advancement of psychedelic medicines in Europe.

Highlighting that the recent shift in perspective towards psychedelics has garnered interest in Europe, the EMA has stated that concerns remain over challenges developers may face in meeting the scientific and regulatory expectations for receiving marketing authorisation for the medicines – holding the workshop as a starting point in working through these issues.

While the meeting marks one small, initial step for the EMA, the organisation’s interest in this developing field of research marks a giant leap for the advancement of the therapies in Europe.

Towards an EU regulatory framework for psychedelics

The meeting heard regulatory perspectives on psychedelic drugs in psychiatry from across Europe, Australia and America, as well as insights on the legal status of psychedelics and their impact on research.

Non-profit organisation PAREA highlighted how Europe is currently facing a mental health crisis with a desperate need for innovation in care, with not a single new medicine out of the 89 approved in 2022 targeting mental health.

The organisation emphasised the obstacles posed by regulation for scientific research and proposed a number of recommendations for a more supportive regulatory framework to help move psychedelic therapies forward, including:

  • Incentives such as regulatory protection: rescheduling psychedelic drugs to enable scientific research.
  • Enhanced EMA support: Utilising Europe’s PRIME scheme which focuses on medicines under development that are not yet authorised in the EU.
  • The establishment of an EU Commission on Novel Mental Health Therapies.
  • Accelerated assessments: Utilising Conditional Marketing Authorisation (CMA) and the EMA’s Adaptive Pathways programme for early patient access.
  • A more predictable reimbursement environment.

Speaking to Psychedelic Health, Tadeusz Hawrot, Founder and Director of PAREA, stated: “An importance of collaboration among different stakeholders felt central to the discussions, highlighting a need for joint effort to address the intricate issues surrounding psychedelic therapies.”

Building on the momentum created at the workshop, Hawrot said that PAREA will be exploring opportunities for a multistakeholder collaborative project as part of the Horizon Europe funding.

“The project would involve professional societies, patient groups, EMA and national competent authorities, addressing a number of most pressing topics related to psychedelic therapies at an intersection of regulation, science, and areas needed for implementing these therapies such as standards of care,” Hawrot explained.

“An upcoming EU Partnership on Brain Health will be an important opportunity to explore in this regard.”

Research and clinical trials

Further discussions focussed on methodological issues related to research and trials.

These surrounded issues with blinding and expectations, the importance of proper dosage justification and documenting dose-response relationships, as well as the need to investigate sub-psychedelic doses and their associations with psychoactive effects and neuroplasticity.

Hawrot commented: “In terms of some key areas addressed yesterday and today, discussion revolved around designing effective trials, the importance and type of therapeutic support, difficulties with using placebos, managing expectations, and how strict drug control policies are slowing down research.

“Exploring what can be standardised in trials, the crucial role of patient input and preferences, and the need for thorough aftercare provisions were further key points.”

The importance of Real World Evidence was also highlighted as a key path for advancing psychedelic therapies in Europe

Some implied next steps discussed were continuing dialogue between developers and regulators, seeking early feedback, and collaborating to address challenges in psychedelic drug development.

Patient representation and care

Ensuring the safe and effective use of psychedelic substances in clinical trials and real-world settings was also a main point of discussion, with patient representatives providing insight on their experience, as well as suggestions for patient care.

In particular, stakeholders including representatives of the Psychedelic Participant Advocacy Network (PsyPAN) highlighted the need for aftercare such as post-integrative therapy and peer support or professional guidance, however, it was also emphasised that these types of support are difficult to regulate.

The importance of patient involvement in research was also discussed, highlighting that patient involvement goes beyond study participation and includes a more active role in research design and decision-making.

Advancing innovation

Providing an environment where innovation can flourish will be vital for advancing psychedelics, and with companies already carrying out trails but hindered by strict regulations and expensive costs changes are needed sooner rather than later.

George McBride, Co-Founder of UK CMO Clerkenwell Health explained that the company is considering a significant investment into the EU to build out centres for the conduct of psychedelic research, querying the competitiveness of the EMA versus other jurisdictions such as the U.S FDA, Australia’s TGA, Health Canada and the UK’s MHRA.

EMA representatives provided assurance that the organisation is ready to be part of a collaborative and supportive effort to establish standards of care and standards for data gathering.

Speaking to Psychedelic Health, Stephen Murphy, CEO of PSYCH, commented: “This workshop is a key moment for the advancement of psychedelic medicines in Europe.

“The interest of the European Medicines Agency and the discussions in this week’s meeting highlights the organisation’s desire for innovation in mental healthcare and willingness to support psychedelic medicines through collaborative efforts.

“Taking action on psychedelic therapies now is a positive move towards preventative care in the area of mental health.

“We are pleased to see these developments at the start of 2024, which is set to be an important year for psychedelics across the globe.”

Harwot concluded: “The workshop made it clear that continuing conversations with regulators and developers and taking a measured approach to regulations are vital.

“It is very encouraging to see the degree of interest from EMA to explore the therapeutic potential of psychedelics and support developers in this field.”

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Policy

UK advisory body issues rapid response on psychedelics for anxiety

POST has confirmed it intends to publish a major briefing on psychedelic drugs to treat mental health conditions in 2024.

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Photo by Shreyas Sane on Unsplash

The UK’s independent Parliamentary Office of Science and Technology (POST) has issued a rapid response on psychedelic-assisted therapy for anxiety disorders.

The response is intended to inform policymakers on the topic as increasing research around psychedelics shows the compounds may hold promise as innovative treatments in the area of mental health.

The rapid response is the second response on psychedelics to come from POST – one of the first independent bodies of its kind in the world that sources independent analysis of public policy issues relating to science and tech for government.

See also  UK advisory body issues rapid response on psychedelic research

The response reads: “The social and economic costs of anxiety disorders in the UK are substantial, both for individuals and society. The Office for National Statistics reported that between 2019 and 2023, ‘depression, bad nerves and anxiety’ was the most prevalent health condition amongst those economically inactive because of long-term sickness.

“Beyond personal impacts, people with anxiety disorders account for a large amount of demand on healthcare. Consultations for GAD increased significantly between 1998 to 2018, and levels of anxiety were reported to increase during the COVID-19 pandemic.”

Responding to research and policy developments

Both rapid responses have been issued following a parliamentary debate discussing psilocybin access in May 2023.

The debate saw a group of crossparty MPs call for the rescheduling of psilocybin to remove barriers to research and demand an urgent review of the evidence for psilocybin’s current status as a Schedule 1 drug under the Misuse of Drugs Regulations 2001, “with a view to rescheduling”.

The Royal College of Psychiatrists, psychedelic access non-profit Heroic Hearts UK, and other leading mental health charities, also wrote letters to the Veterans Minister and the Minister of State for Crime, Policing and Fire, urging them to champion access for patients in the UK.

See also  UK MPs welcome psychedelic research, call for scheduling review

The rapid response covers psychedelics for anxiety including Treatment options for anxiety disorders, Lifestyle factors, Psychological treatments (psychotherapy), Pharmacological treatments, Psychedelic drugs for anxiety, Challenges in undertaking research involving psychedelics, Research examples and Ongoing research.

Joanna Neill, Professor of Psychopharmacology at the University of Manchester, acted as an external peer reviewer.

At the time of the first rapid response publication, speaking to Psychedelic Health, Neill commented: “It is very encouraging that Parliament is starting to engage with the enormous clinical potential of psychedelic medicine, particularly at a time when mental health disorders are at an all-time high.

“New therapies are urgently needed and psychedelics could provide just that. Given the weight of evidence presented in this new POST note, enabling safe patient access on the NHS must be a key priority for Parliament.”

POST has confirmed it intends to publish a major briefing on psychedelic drugs to treat mental health conditions in 2024.

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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