Connect with us

Policy

New MHRA guidance will help with access to psychedelic medicines

Albert Labs has said it embraces the UK’s new guidance on Real-World data in clinical trials.

Published

on

First CPT code for psychedelic therapies released

Albert Labs has highlighted that the UK’s new guidance on Real-World data will accelerate access to psychedelic treatments.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently confirmed that it would be updating its guidance on the use of Real-World data. It stated that the use of this data from clinical trials would help toward regulatory approval for new medicines at a faster pace.

Albert Labs, which is accelerating access to psychedelic-based medicines for patients with urgent and unmet needs, has said that this new guidance is consistent with its strategy. The company is one of the first psychedelic drug development companies to use a Real World Evidence (RWE) approach for regulatory approval.

Dr Malcolm Barratt-Johnson, Albert Labs CMO, commented: “We embrace this regulatory guidance particularly in the investigation of psilocybin-assisted psychotherapy.

“Albert Labs consider that carefully designed pragmatic trials that implement a progressive use of Real-World evidence, will greatly advance the understanding of the safety, effectiveness, impact, and optimal clinical use of this new therapy.”

See also  New UK guidance on real-world data is good news for psychedelics

Albert Labs is pursuing the Real-World Data pathway in the licensing of their natural psilocybin medicine, which has been endorsed by leading hospital centres in the UK.

This expedited pathway offered by the UK regulatory system will accelerate access to treatment, benefiting patients, not only in the UK but the rest of Europe, Canada and the US.

The guidance emphasises that a study or studies considered under this guidance need to be of the same standard as would be expected from a traditional Randomised Control Trial (RCT), and further states that well-designed and conducted prospective RCTs provide a high level of evidence irrespective of the categorisation of the data source.

“Our approach, in the investigation of psilocybin-assisted therapy, has been designed to reduce risk, improve outcomes, and importantly to speed up access to those patients who will benefit from this therapy,” added Barratt-Johnson.

“We believe Real World Evidence will play a vital role in helping safeguard the development of this promising mental health treatment.”

Albert Labs says is following the MHRA’s guidance and taking the necessary regulatory and scientific steps required for authorisation of a new treatment using an RWE approach.

The trials are focused on early access to treatment and the company expects to treat patients suffering from cancer-related distress in the first half of 2022.

[activecampaign form=52]

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Policy

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

Published

on

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.

Continue Reading

Policy

UK advisory body issues rapid response on psychedelics for PTSD

Published

on

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.

Continue Reading

Policy

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

Published

on

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.”

Continue Reading

Trending

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.

Copyright © 2023 Psych Capital Plc