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UK continues to delay on psilocybin rescheduling

MP Crispin Blunt raised the question of rescheduling psilocybin in Parliament this week.

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UK continues to delay on psilocybin rescheduling

UK MP Crispin Blunt raised the question of rescheduling psilocybin in Parliament this week after PM Boris Johnson gave Blunt personal reassurance back in May that this would be considered for clinical research purposes.

As the mental health crisis continues to skyrocket, emerging evidence is pointing to psychedelic compounds, such as psilocybin, holding promise as innovative treatment solutions for resistant mental health disorders.

Chair of the Conservative Drug Policy Reform Group (CDPRG), Blunt, raised the question of rescheduling psilocybin this week, asking the Prime Minister if he is willing to “cut through” the current barriers to research given the Prime Minister’s commitment to UK bioscience and the potential for improving mental health treatments for conditions such as depression, trauma and addiction. 

Johnson said that he would consider the Advisory Council on the Misuse of Drugs’ (ACMD) recent advice on reducing barriers to research with controlled drugs, and would “get back to him as soon as possible”.

Blunt commented: “I am trying to make clear the evidence-free position of the Government’s current scheduling of psilocybin and psychedelics and the cost that the current scheduling is imposing on British scientists and researchers which is making research very difficult to do.”

Back in April, Secretary of State for Health and Social Care, Matt Hancock, spoke at the Association of the British Pharmaceutical Industry (ABPI) annual conference, setting out a vision for the UK to become a life sciences superpower, wanting “to deliver on our vision to create the most advanced and data-enabled clinical research environment in the world”.

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In July, the Government set out its ten-year plan to help fulfill this vision following its response to COVID-19, which it says would focus on “harnessing private sector expertise and removing unnecessary bureaucracy so that the UK’s most knowledgeable industry leaders can tackle future healthcare challenges at speed and at risk – with the aim of changing people’s lives for the better.” This strategy includes developing tools to address mental health conditions.

To add to the already pressing need for mental health solutions, data from the Office for National Statistics (ONS) revealed that depression rates had doubled since the COVID-19 pandemic – with 21 per cent of adults experiencing some form of depression in early 2021 compared to 10 per cent before the pandemic.

Earlier this month, Health and Social Care Secretary, Sajid Javid, spoke at the Global Mental Health Summit 2021, noting that: “We’re at an important moment for mental health. The strains of the pandemic have meant that the issue of mental health has been in the public consciousness like never before,” and that “the silent pandemic of poor mental health has taken too many people before their time, and now is the time to act with the same sense of urgency as we have done for other major killers.”

Although psychedelics research is carried out in the UK, psilocybin’s status as a Schedule 1 drug makes this research extremely costly, with many barriers associated with acquiring a licence to handle the compound. These barriers hinder research and development in an area that could potentially revolutionise the treatment of mental health in the UK.

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“I hope that my focus this week will have encouraged attention to it. The Health Secretary offered me a meeting so that he could be brought up to speed with the issue in the wake of my question to him on Tuesday,” said Blunt.

“I am trying to make clear the very substantial potential benefits that could arise, if the pharmacology that would come from psychedelics can then be used in association with psychotherapy to much improve the outcomes around treatment of the most debilitating serious mental health conditions. 

“Every day we delay – delaying for reasons that are not based on evidence – we are causing harm. So, we need to get on with this – we are causing harm to people, we are causing harm to our economy, and we are causing harm to our reputation for supporting science. And this is sufficiently important to justify senior ministers’ attention.

“The outcome of policy after 50 years of trying to manage the system we’ve got under the Misuse of Drugs Act 1971 is catastrophic by any reasonable standard. And so, CDPRG is addressing these catastrophic bad outcomes we have from the current framework for drugs policy.

“What I have certainly observed is, frankly, the rich contempt from the science and research community for the policy and the authors of that policy. What I am trying to do through CDPRG is get quality, academic peer-reviewed advice from researchers employed by the CDPRG, to help me and other colleagues bridge that gap between evidence and science with the policy community so that we get to a place where we are working together to try and advance the wider national interest and the wider public interest.”

See also  Data shows combination psilocybin therapy effective for TBI and PTSD

Speaking to the Minister for Crime and Policing, Kit Malthouse, Blunt noted that: “In 2019, 90,503 of our fellow citizens were driven to suicide by their depression or trauma, or their rock-bottom in addiction has been death. If there is any scale of potential for these drugs, and it appears that there is, any further delay in getting the science and research going is not defensible—in fact, it is a morally disgraceful abrogation of our duty to the public good.”

Citing the rescheduling of cannabis-based medicine Epidyolex into Schedule 5 following advice from the Medicines and Healthcare products Regulatory Agency (MHRA) and of the ACMD, Malthouse said rescheduling would be considered if and when a psilocybin-based medicine is approved by the MHRA.

Malthouse said: “As a founder of the all-party group on life sciences, I am well aware of the potential of any number of compounds to assist us in the constant battle against mental and physical illness, and of the need for this country to lead in research that might alleviate the problem, not just here, but in the rest of the world.”

A survey carried out by YouGov in collaboration with PsiloNautica and Drug Science earlier this year revealed that a clear majority of UK citizens are in favour of rescheduling psilocybin for research purposes, as well as support for the use of psilocybin in palliative care and for treating military veterans suffering from psychiatric disease.

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Policy

Psychedelics are here, now: preparing psychiatry for a psychedelic future

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Psychedelics are here, now: preparing psychiatry for a psychedelic future

An emerging body of evidence is showing psychedelics as promising treatments for mental health conditions, and psychiatry needs to be prepared for their arrival, say researchers.

Recent years have seen an increasing amount of scientific evidence pointing to the potential of psychedelics as treatments for mental health conditions such as anxiety, depression, and PTSD. So far, this evidence has led countries such as Australia, Canada, and the US to allow special access to these medicines for select patients.

In particular, MDMA and psilocybin have produced robust results – now in Phase III trials – that show their efficacy for PTSD and treatment-resistant depression, respectively. 

The developments around these two substances may lead to their approval as licenced medicines in the near future, with Lykos Therapeutics MDMA-assisted therapy for PTSD already receiving US Food and Drug Administration (FDA) acceptance and priority review for a New Drug Application (NDA), for example.

See also  UK advisory body issues rapid response on psychedelics for PTSD

In a new article published in the British Journal of Psychiatry, researchers emphasise the need for the psychiatry profession to prepare for this possible outcome, and discuss how health systems might respond to these developments.

The authors write: “Given the rapidly emerging body of evidence of efficacy for psilocybin and MDMA, people’s great need for innovative treatments and the move towards approval in some countries before licences are awarded, it seems likely that these two drugs will become a part of psychiatric practice for many in the foreseeable future. The psychiatry profession and practising psychiatrists need to prepare for this.”

Supporting patient access

Medicines must undergo rigorous, double-blind randomised controlled trials (RTCs) to reach patients under approved licensing. 

However, the authors highlight that this model poses challenges due to the high cost of trials, commercial incentives for indication testing, and socioeconomic/demographic factors impacting decisions on where a company makes a licensing application – such as population size and income.

This can mean that cancer treatments are prioritised over physiatric treatments, for example, and can lead to low- and middle-income countries waiting decades to gain access to new medicines. 

The researchers suggest that off-license administration may provide a solution.

“Already psychiatrists in many countries are using ketamine ‘off licence’ to treat people with resistant depression. There is now comparable evidence of safety and efficacy for psilocybin and MDMA to allow, with the patients’ informed consent, competent clinicians to try them out ‘off licence’ as well as in severe illnesses when other treatments have failed,” write the authors.

“One of the main arguments from patients and their carers is the distress that they cannot access treatments of proven efficacy until a company chooses to market them; these people are totally disempowered. In Australia, the issue of drug supply outside the usual drug company medicine marketing model was solved by a charity sourcing the medicines from accredited manufacturers. This model could be used elsewhere.”

The authors also highlight that ensuring patient access to psychedelics will need a country-by-country approach, taking into consideration the unique challenges of each place.

Using the UK as an example, they highlight that the Advisory Council on the Misuse of Drugs (ACMD) “appear to be acting under the misperception that a marketing authorisation generated by a pharmaceutical company is necessary to change the Schedule 1 status of these compounds in the Misuse of Drugs Regulations.”

However, the UK’s Chief Medical Officer confirmed there was ample real-world evidence to support the legalisation of medical cannabis in 2018.

“There is now indubitably better evidence for psilocybin and MDMA in their respective Australian-approved indications than there was then for medical cannabis,” the authors write, suggesting regulatory controls for psychedelics such as a register of practitioners and supervised data collection for efficacy and adverse effects.

Training psychedelic psychiatrists 

While scientific data may be mounting up and regulation changes are slowly creeping in across the globe, the roll-out of psychedelic therapies will also depend on having trained psychedelic therapists.

Lack of education and training has resulted in hesitation from NHS practitioners to prescribe medical cannabis, the authors highlight, so systematic training and relevant education will be vital if psychedelic medicines are to reach patients.

“By utilising innovative technologies, many of the educational and administrative tasks can be undertaken remotely, and we can learn from other countries, such as Australia, as to how to coordinate the delivery of excellent treatment,” the authors write.

“It is up to the gamut of professionals and organisations – for example, Royal College of Psychiatrists, the Chief Medical Officer, ACMD and other groups, to take the initiative early.”

The authors also suggest that the UK should establish a working group to explore the implementation of psychedelic therapies.

“We need to be ready for a change in the law which would signal a turning point in the provision of better treatment for some of the most incapacitating illnesses in medicine,” the authors conclude.

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Markets & Industry

Major deals continue positive trajectory for psychedelics in 2024

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“Enhanced Consciousness Index” tracked by new psychedelics ETF

Psychedelics started 2024 with a bang, and the innovative medicines are continuing to gain traction as the year progresses. This week saw one of the globe’s top five biggest pharmaceutical companies – AbbVie – enter the market, while Enveric and MindBio signed a $66.5 million deal.

2024 set off to a strong start for psychedelic medicines with several watershed moments that are setting the stage for the sector’s acceleration.

These include developments such as the FDA’s acceptance of Lykos Therapeutics’ NDA for MDMA-assisted therapy for PTSD, Beckley Psytech’s securement of $50M investment from atai Life Sciences to expedite its assets through Phase 2 trials, a European Medicines Agency meeting on regulating psychedelics, and the confirmation from the UK’s independent policy body POST that it will publish a major briefing on psychedelic drugs to treat mental health conditions later this year, among others.

The positive developments for the industry are continuing, with this week seeing pharmaceutical company AbbVie – which has a clinical pipeline covering neuroscience, immunology, oncology, and eyecare – entering the industry through a new $65 million partnership with psychedelic drug developer Gilgamesh Pharmaceuticals.

Next generation neuroplastogens

The companies have stated they will be working together to discover and deliver next-generation psychedelics for mental health conditions such as anxiety, depression, and PTSD, as well as addiction.

AbbVie has highlighted the challenges posed by first-gen psychedelics including necessitating in-office administration and concomitant supportive care due to their hallucinogenic component – elements that could hinder the adoption and scale-up of these medicines.

See also  MDMA for PTSD receives priority review for New Drug Application

Gilgamesh Pharmaceuticals is working on the development of next-gen compounds that aim to improve the safety and efficacy of first-generation psychedelics and remove the hallucinogenic component, including a short-acting 5-HT2A agonist and an Ibogaine analogue.

In a press statement, Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research at AbbVie, commented: “Significant unmet need remains for people living with psychiatric disorders and we know that to innovate in this field, we need to pursue novel technologies and approaches.

See also  UK advisory body issues rapid response on psychedelics for PTSD

“We look forward to working with Gilgamesh’s world-class team to advance the development of novel neuroplastogens and pave the way for additional treatment approaches in psychiatry.”

Jonathan Sporn, M.D., chief executive officer at Gilgamesh Pharmaceuticals, added: “We are thrilled to partner with AbbVie, a global pharmaceutical company focused on innovation in psychiatric care, to address the pressing challenges in mental health treatment.

“Our collaboration will pioneer research of a new generation of therapies that hold great potential for improving patient outcomes.”

AbbVie is now the latest major pharmaceutical company to enter this market, following the likes of Janssen and Janssen and Otsuka Pharmaceutical, indicating that mainstream pharma is taking the promise of psychedelic medicines seriously.

However, this was not the only major deal to take place in the psychedelics market this week.

Enveric Biosciences also signed a $66.5 million non-binding term sheet with MindBio Therapeutics to out-license its novel psilocin prodrug candidate for mental health disorders.

Similar to Gilgamesh Pharmaceuticals, Enveric and MindBio focus on the development of next-generation neuroplastogens for that have reduced the hallucinogenic component.

Under the non-binding term sheet, Enveric will out-license a class of Novel Psilocin Prodrugs (NPP) to MindBio – a group of molecules that the company says are designed to be metabolised specifically to release therapeutic levels of systemic psilocin at varying rates.

In a press statement, Joseph Tucker, Ph.D., Director and CEO of Enveric, commented: “We look forward to working with MindBio’s team, which is pioneering an important part of the exciting psychedelic space, focused on controlling dose to reduce or eliminate hallucinations associated with these powerful compounds.

“This non-binding term sheet highlights the potential synergies between the Enveric and MindBio approaches to leveraging psychedelic-based compounds to target specific signaling pathways in the brain for the treatment of neuropsychiatric conditions.”

“We are pleased to explore an opportunity to draw on the molecular discovery engine at Enveric and believe this novel and patented asset significantly strengthens our intellectual property pipeline and aligns with our strategy to develop innovative, protected compounds with fine-tuned formulation and dosing strategies,” added CEO of MindBio, Justin Hanka.

“We look forward to the prospect of progressing this asset into clinical trials as we seek to bring important and beneficial therapies to patients in need.”

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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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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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