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Law Firm Article Australia: Regulatory shift provides opportunities for new methods of treatment using psychedelic substances



On 3 February 2023, the Therapeutic Goods Administration (TGA) announced a major regulatory shift that will have significant impacts for the treatment of mental health conditions. Australia is now the first country to regulate psychedelic substances as medicines on national level.[1]

In our recent article, we explored the most promising psychedelic substances, their potential therapeutic uses, and how they are currently regulated in Australia and around the world. At the time, psychedelics were prohibited substances that were only available to be used in patients enrolled in clinical research. The TGA has announced that certain psychedelics – MDMA and psilocybin (the active ingredient in ‘magic mushrooms’) – will, from 1 July 2023, be regulated as controlled drugs, meaning that they can be prescribed by approved psychiatrists for use in treating patients with certain mental health conditions.

The regulatory scheme – how it works

The Poisons Standard

The Commonwealth Poisons Standard (Poisons Standard) classifies medicines and poisons into ten schedules according to the degree of control that is exercised over their availability to the public.  Each Australian state and territory has adopted the Poisons Standard.  The possession, sale and supply of substances listed in the different schedules of the Poisons Standard, including psychedelics, is regulated by local state and territory legislation.

MDMA and psilocybin have, up until now, been included in Schedule 9 (Prohibited Substances) of the Poisons Standard, meaning that they were prohibited from supply (other than for use in an approved clinical trial).

The TGA’s recent decision

On 3 February 2023, the TGA confirmed that the Secretary of the Department of Health and Aged Care has decided to amend the current Poisons Standard to include MDMA and psilocybin in Schedule 8 (Controlled Drugs) with effect from 1 July this year.  Following this amendment, these substances will be able to be supplied on prescription by psychiatrists approved by the TGA for use in treating patients with particular mental health conditions.

What are the circumstances in which psychedelics can be prescribed?

Psychiatrists who have been approved under the Authorised Prescriber Scheme (Scheme) will now be able to prescribe:

  • Psilocybin for treatment resistant depression; and
  • MDMA for the treatment of post-traumatic stress disorder.

There are currently no approved products containing psilocybin or MDMA on the Australian Register of Therapeutic Goods (ARTG). Following the TGA’s decision, authorised psychiatrists will be able to access and supply ‘unapproved’ medicines containing these substances for their patients under the existing Scheme.

The Authorised Prescriber Scheme

Generally, therapeutic goods must be included in the ARTG before they can be supplied in Australia. Under the Scheme however, authorised medical practitioners can supply unapproved therapeutic goods directly to patients under their immediate care without patient specific approval from the TGA.

There are two pathways under the Scheme – the ‘standard pathway’ and the ‘established history of use’ pathway.

(a) The standard pathway

For a medical practitioner to become an authorised prescriber under the standard pathway, they need to be approved by a Human Research Ethics Committee (HREC) or specialist college and apply to the TGA for approval as an authorised prescriber.

Applications for HREC approval or specialist college endorsement usually need to include evidence to justify the use of the unapproved product, including its clinical justification. Generally, where therapeutic goods are indicated for highly specific medical conditions (as is the case with psilocybin and MDMA), medical practitioners will need to demonstrate specialist experience to be approved as an authorised prescriber.

(b) The established history of use pathway

Approval from a HREC or specialist college endorsement is not required to supply products included in the list of medicines with an established history of use (published by the TGA here) under the Scheme. Psilocybin and MDMA are not currently included on the list, however, they may be in future (together with certain medicinal cannabis products that are currently included in the list).

Medical practitioners who supply products under either pathway of the Scheme are required to report the number of patients they treat to the TGA every six months.

No advertising is permitted

Psychedelics, like other prescription products, must not be advertised to the public.  They may only be advertised to health professionals.

What constitutes ‘advertising’ of therapeutic goods is very broad and includes any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods. This includes material posted on the internet (including websites and in social media), articles published in newspapers and magazines, photographs, broadcast material, and displays on posters and notices.

There are very serious penalties that apply to the advertising of prescription medicines.

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Press Release: PsychedelicNewsWire Named Official Media Sponsor of the 4th Annual Psychedelic Therapeutics and Drug Development Conference




LOS ANGELES, May 17, 2024 (GLOBE NEWSWIRE) — PsychedelicNewsWire (“PNW”), a specialized communications platform for the psychedelics sector and one of the 60+ brands powered by IBN (“InvestorBrandNetwork”), is pleased to announce that it will be the Official Media Sponsor for the 4th Annual Psychedelic Therapeutics and Drug Development Conference (“the conference”), an industry flagship event dedicated to research and development of psychedelics in the healthcare space hosted by Arrowhead SciTech Conferences & Events (“Arrowhead”). The event will be held at the iconic Revere Hotel Boston Common, 200 Stuart Street, Boston, MA 02116 on 23-24 May 2024

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individualized treatment

Risks of Psychedelics for People with Personality Disorders




While psychedelics have shown promise in treating certain mental health conditions, a recent study suggests they may pose risks for individuals with personality disorders. The findings underscore the importance of careful screening and personalized approaches in psychedelic-assisted therapy.

Navigating the Psychedelic Landscape: Potential Risks for Individuals with Personality Disorders

Psychedelics, including substances like psilocybin and LSD, have gained significant traction in recent years for their potential therapeutic benefits in treating mental health conditions such as depression, anxiety, and PTSD. However, a recent publication in the Journal of Psychopharmacology has raised concerns about the suitability of these substances for individuals with personality disorders.

The study surveyed individuals who had used psychedelics and who were also diagnosed with personality disorders. A considerable number of respondents reported negative and persistent psychological impacts following their psychedelic experiences. Notably, these included heightened anxiety, paranoia, mood instability, and an exacerbation of existing personality disorder symptoms.

Researchers suggest that the vulnerability of individuals with personality disorders to the adverse effects of psychedelics may stem from pre-existing challenges in emotional regulation, self-identity, and interpersonal relationships. The profound and introspective nature of psychedelic experiences can intensify these issues, potentially leading to psychological distress and symptom aggravation.

This research highlights the critical need for thorough screening and assessment in the context of psychedelic-assisted therapy. It suggests that individuals with personality disorders might require tailored therapeutic approaches and robust support systems to navigate potential risks and to secure safe and positive outcomes.

Why It Matters

The burgeoning interest in psychedelic therapy underscores the necessity to discern both the potential benefits and risks across different demographic groups. This study contributes valuable insights, particularly for clinicians and researchers, stressing the importance of personalized treatment plans and the cautious consideration of individual vulnerabilities when administering psychedelic-assisted therapy.

Potential Implications

The findings from this study emphasize the need for ethical and responsible practices within the field of psychedelic-assisted therapy. There is a pressing requirement for the development of detailed screening protocols that can identify individuals who may be more susceptible to the adverse effects of psychedelics. Furthermore, crafting specialized therapeutic strategies that cater specifically to the needs of individuals with personality disorders is essential for ensuring their safety and overall well-being during and after undergoing psychedelic experiences.

The Bigger Picture

The debate surrounding the therapeutic use of psychedelics is complex, with various factors influencing the suitability of these treatments for different individuals. While there are promising results in general populations, the nuanced needs and potential vulnerabilities of those with personality disorders require careful consideration to prevent harm and maximize therapeutic outcomes. This necessitates ongoing research, improved clinical protocols, and a commitment to patient-centered care in the burgeoning field of psychedelic medicine.

Source: Science Alert

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Treating Depression: Psychedelics vs. Antidepressants




Recent research suggests that psychedelics and traditional antidepressants, while both potentially effective in treating depression, work through distinct mechanisms. Understanding these differences could lead to more personalized and effective treatment approaches. Psychedelics vs. Antidepressants: What are the key differences?

Unlocking the Mysteries of Depression Treatment: Psychedelics vs. Antidepressants

The quest for effective depression treatments continues to be a significant focus in mental health research. Traditional antidepressants, like selective serotonin reuptake inhibitors (SSRIs), have been a mainstay in treatment, prescribed widely despite varying efficacy among individuals and often accompanying unwanted side effects. In contrast, psychedelics have recently garnered attention for their rapid and enduring antidepressant effects observed in clinical trials.

A recent study has delved into the distinct mechanisms of action of SSRIs and psychedelics, illuminating how they uniquely influence the brain and potentially alleviate symptoms of depression. SSRIs primarily increase serotonin levels in the brain, which is believed to enhance mood and diminish depressive symptoms. However, this process can require several weeks to manifest noticeable effects, and not all patients respond favorably to SSRIs.

Conversely, psychedelics such as psilocybin, found in “magic mushrooms,” operate through a different mechanism. Research indicates that psilocybin’s antidepressant effects are not directly due to elevated serotonin levels. Instead, psilocybin is thought to promote neuroplasticity, the brain’s capacity to reorganize and form new neuronal connections. This heightened neuroplasticity may facilitate more adaptable thought patterns and an improved ability to process emotions, contributing to the rapid and sustained antidepressant effects seen in clinical trials.

Moreover, the study examined the role of the 5-HT2A serotonin receptor, a primary target for both SSRIs and psychedelics. While SSRIs inhibit this receptor’s activity, psychedelics activate it. Intriguingly, blocking the 5-HT2A receptor did not reduce psilocybin’s antidepressant effects, suggesting that its therapeutic benefits originate from other pathways.

Psychedelics vs. Antidepressants: Why It Matters?

Understanding the distinct mechanisms by which psychedelics and antidepressants affect the brain is crucial for the development of more personalized and effective treatment strategies for depression. This knowledge could lead to enhanced patient selection for specific treatments, reducing trial and error while optimizing outcomes. Furthermore, exploring the unique properties of psychedelics may pave the way for novel antidepressant medications that are quicker acting and have fewer side effects.

Potential Implications

This research could catalyze a shift in depression treatment paradigms, moving from a one-size-fits-all approach to more targeted therapies. By pinpointing the specific mechanisms that underlie different antidepressant interventions, clinicians can customize treatment plans based on individual patient profiles and needs. This personalized approach could improve treatment success rates and enhance the quality of life for individuals battling depression.

What Next?

While the study of psychedelics for therapeutic purposes is still in its nascent stages, the initial findings are promising and suggest that psychedelics may offer a valuable addition to the arsenal of tools for combating depression and other mental health conditions.

Source: Neuroscience News

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