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UK MPs welcome psychedelic research, call for scheduling review

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Photo by Jurica Koletić on Unsplash

In the latest development for psychedelics in the UK, the Home Affairs Committee Drug Report has seen MPs call for a review of drug scheduling in the country, welcoming the government’s commitment to psychedelic research.

The report highlights barriers to research that are preventing the UK from developing its own psychedelic research industry “which has an emerging and growing global market.”

Exploring topics such as legislative framework, the Government’s 10-year Drugs Strategy, county lines, health and criminal justice-led harm reduction, cannabis and more, the report recommends that the Government balances its criminal justice response to drugs with an increased public health response.

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It highlights that the Misuse of Drugs Act 1971 – which came into force more than 50 years ago – is in urgent need of reform as it has “failed to prevent drug use and has failed to reduce drug-related deaths and drug-related offending”, as well as disproportionately impacting ethnic minorities. 

Restrictions in the Act and its supporting Act, the Misuse of Drugs Regulations 2001, regulate how drugs are licensed and handled – and psychedelic compounds such as LSD and psilocybin – are included as Schedule 1 drugs under it. This makes licensing costs for research incredibly high, creating barriers to scientific knowledge and advancements. 

While these barriers do exist, a number of initiatives have nonetheless been established in the UK looking at psychedelic research, such as a partnership between King College London’s Institute for Psychiatry, Psychology and Neuroscience, South London NHS Foundation Trust and COMPASS Pathways to investigate the use of psychedelics for Treatment-Resistant Depression (TRD).

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

With this rise in clinical evidence that psychedelic medicines may hold promise as treatments for a number of mental health conditions, the MPs call for an urgent reclassification of psychedelic compounds from Schedule I to Schedule II.

“We welcome the UK Government’s commitment to reducing barriers to researching psychedelic drugs under Schedule 1 to the 2001 Regulations.” the report states. 

“Pending the outcomes of the ACMD’s ongoing review of Schedule 1 controlled drugs, we recommend the UK Government urgently moves psychedelic drugs to Schedule 2 in order to facilitate research on the medical or therapeutic value of these drugs.”

And continues: “Beyond the potential benefit psychedelics may have to health, these barriers may also prevent the UK from developing its own psychedelic research industry, which has an emerging and growing global market. The barriers researchers face may therefore stymie our understanding of controlled drugs, undermine innovations in medical treatment and undermine the UK as a global leader in science and medicine.”

While the Advisory Council on the Misuse of Drugs (ACMD) is currently conducting a review of barriers to researching Schedule 1 Drugs – which is allegedly in “advanced” stages – the report recommends that a wider review is required, recommending that the Home Office “must reform the classification system and the scheduling system based on the findings of that review” and that updated assessments should be conducted every 10 years. 

Speaking to Psychedelic Health, the independent non-profit reform group, Drug Science, which provided evidence for the report, stated: “Drug Science were pleased that the evidence we gave to the Select Committee played a significant role in this report. 

“Specifically, we support their call for reform of the drug laws to reduce harms and facilitate research particularly the re-scheduling of psychedelics like psilocybin for treatment purposes. 

“It is difficult to comprehend that such a well-researched and thoughtful report should be simply dismissed by the Home Office. Their rejection of policies proven to save lives confirms the urgent need for a change in the current processes, and the need for a health-centred approach. 

“Drug Science hopes that the Department of Health will be more supportive.”

Timmy Davis, Psychedelics Lead at CDPRG and Policy Director at Psilocybin Access Rights (PAR), added: “The number of influential voices within parliament calling for the rescheduling of psilocybin and other psychedelics continues to grow. The Home Affairs Committee are the most recent to chime in, echoing and amplifying those from the public and civil society, including the Royal College of Psychiatrists and two of the most influential UK mental health charities, CALM and SANE.

“There has never been a clear voice of opposition, but the Home Office continues to hide behind an upcoming report by the Advisory Council on the Misuse of Drugs (ACMD). This report will make recommendations on the removal of barriers to researching Schedule 1 drugs (the first iteration of which was commissioned in 2017), despite this being completely unnecessary for the Home Office to take action to reschedule.

“It is another question entirely whether the recommendations of the ACMD’s report, which will almost certainly not recommend rescheduling, will be enacted by the Home Office who have a history of ignoring or acting in contradiction to their advice.

“The newly released Home Affairs Committee report on the other hand is clear – 50 years on from the enactment of the Misuse of Drugs Act 1971, a wholesale review of UK drugs policy is long overdue. Amongst a variety of measures to better deal with the risks posed by currently controlled drugs, such as the facilitation of festival drug checking and diamorphine-assisted treatment, they have recommended a one-time review of the Class and Schedule status of all controlled drugs. If psychedelics were found to be better placed within Schedule II or lower, research and prescription would be greatly facilitated.

“It would rectify the unjustified levels of control inflicted upon these substances, aligning scheduling and classification with the most recent evidence of harms and utility. Since the psychedelics were first controlled, there has been no review of the evidence – and given the number of times such recommendations have been made, such large-scale reform is an unlikely outcome of the release of this particular report.

“That said, it is becoming increasingly clear that the appetite for reform within parliament is quickly becoming a reflection of the views of the UK public, who want to see increased access to psychedelic-assisted therapies. It is gratifying to see the impact that our Psilocybin Rescheduling Project is continuing to have within parliament.

“As the Psilocybin Access Rights campaign continues to increase public pressure, and the CDPRG continues to troubleshoot the misgivings within the Home Office, we remain optimistic that HMG will grasp the scale of the opportunity and reschedule psilocybin ahead of market authorisation.”

Markets & Industry

FDA Grants Breakthrough Therapy Designation to Beckley and Atai’s 5-MeO-DMT Program

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Last week, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to 5-MeO-DMT, also known as toad venom, in a significant advancement for psychedelic medicine.

The designation was given to BPL-003, a novel intranasal formulation of 5-MeO-DMT developed by Atai Life Sciences and Beckley Psytech. 

The decision by the regulatory body aims to expedite the development of BPL-003 as a treatment for adults with treatment-resistant depression (TRD), a condition affecting up to 30% of the 280 million individuals worldwide living with depression.

The FDA’s decision follows promising results from a Phase 2b clinical trial, which demonstrated that a single dose of BPL-003 led to rapid and sustained reductions in depressive symptoms within 24 hours, with effects lasting up to eight weeks. Notably, the majority of participants were ready for discharge just 90 minutes post-treatment, highlighting the potential for a scalable, in-clinic treatment model.

5-MeO-DMT is a naturally occurring psychedelic compound found in several species. It is most famously present in the venom of the Incilius alvarius (Sonoran Desert toad), as well as in other Bufo toads. It also occurs in certain plants, including Virola species and Anadenanthera peregrina.

The companies state that BPL-003 is designed to deliver rapid and durable antidepressant effects from a single dose with a short therapeutic experience. The Breakthrough Therapy Designation facilitates intensive FDA guidance to support the advancement of BPL-003, with Phase 3 trials expected to initiate in the second quarter of 2026, subject to alignment with the FDA.

Other Breakthrough Therapy Designations in Psychedelic Compounds

The FDA has previously granted Breakthrough Therapy Designations to other psychedelic compounds, underscoring the growing recognition of psychedelics in mental health treatment:

  • Psilocybin: In 2018, the FDA granted Breakthrough Therapy Designation to psilocybin for the treatment of treatment-resistant depression. A second designation followed in 2019 for major depressive disorder. 
  • MDMA: In 2017, the FDA designated MDMA as a Breakthrough Therapy for the treatment of post-traumatic stress disorder (PTSD). 
  • LSD: In March 2024, the FDA granted Breakthrough Therapy Designation to an LSD compound for the treatment of generalized anxiety disorder (GAD), based on Phase 2b trial data showing rapid and sustained improvements in anxiety symptoms.

Global 5-MeO-DMT Research Landscape

Beyond BPL-003, several organizations are exploring 5-MeO-DMT’s therapeutic potential:

  • The Usona Institute has completed a phase 1 study of 5-MeO-DMT and is currently analyzing the results.
  • GH Research is currently studying a 5-MeO-DMT compound for treatment-resistant depression and is in phase 2 trials.

These initiatives reflect a global interest in harnessing the therapeutic potential of 5-MeO-DMT for various mental health conditions.

The FDA’s Breakthrough Therapy Designation for BPL-003 marks a pivotal moment in the development of psychedelic-based treatments for mental health disorders. With ongoing clinical trials and increasing regulatory support, 5-MeO-DMT is emerging as a promising candidate in the evolving landscape of psychiatric medicine.

Original picture by Alan Schmierer on Wikimedia Commons. Edited using AI tools.

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Insight

Is Ketamine Therapy Only Reaching The Wealthy? Dr. Celia Morgan On Expanding Equitable Access

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Dr. Celia Morgan is one of the UK’s leading figures in ketamine and psychedelic research, especially in the domain of addiction and mental health.

Based at the University of Exeter, she holds the Chair of Psychopharmacology and leads trials exploring how ketamine, paired with psychotherapy, can break cycles of relapse in substance misuse.

Morgan has led some of the largest clinical trials on ketamine-assisted therapy for alcohol use disorder and will be speaking at the upcoming PSYCH Symposium: London 2025, to be held at Conway Hall on December 4.

“I think that the most promising findings from our work with ketamine are of the sense of agency and autonomy in their recovery that the people we are working with experience,” she told Psychedelic Health in a written interview.

Still, she thinks several key challenges need to be tackled for these treatments to be able to reach more people. One of the biggest of such challenges is ensuring equitable access to these treatments.

“We see a relatively homogenous and privileged group in most studies, our work has tried to address this,” she said.

Building the infrastructure to safely deliver these treatments in public healthcare systems is another big challenge for the industry, she said.

Yet the healthcare sector can also take advantage of Ketamine’s regulated status to allow for a faster roll-out, when compared to other psychedelics like MDMA or psilocybin.

“Some of the recent recommendations by the Royal College fo Psychiatrists are steps on the way towards more widespread use,” she said.

What distinguishes Morgan in the psychedelics field is her dual commitment. She studies the risks and harms of recreational ketamine use while simultaneously designing controlled, clinical applications for it.

One of her flagship projects is Exeter’s KARE trial (Ketamine for Reduction of Alcohol Relapse), which blends ketamine infusions with psychotherapy for patients with alcohol use disorder. Early published data show dramatic improvements in abstinence rates during six-month follow-ups, far exceeding baseline relapse rates. Morgan has also worked on trials for gambling disorder and other behavioral addictions, expanding the frontier of what ketamine-assisted therapy might treat.

Morgan also plays a role in academia’s response to the psychedelic renaissance, she’s a co-lead on Exeter’s postgraduate certificate in psychedelic studies, a program designed to train clinicians, researchers, and therapists in the science and ethics of psychedelic medicine.

“I think its important to keep on with our efforts to study, regulate and roll out these treatments principally for the patients who might benefit from psychedelics as I have seen first hand in my work,” she said.

Picture is extracted from an interview with Dr. Morgan at PSYCH Symposium’s 2022 edition.

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News

Germany Pioneers Compassionate Psilocybin Access for Treatment-Resistant Depression in EU First

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By Jody Chu and James Bunn.

Germany has recently taken a landmark step by introducing compassionate access to psilocybin for patients with treatment-resistant depression (TRD), marking the first such programme in the European Union. This initiative allows eligible patients to receive psilocybin treatment outside of clinical trials under a legal framework designed for compassionate use.

Founder of Drug Science – Prof David Nutt says “It is pleasing to see such a rational development in the provision of proven therapy to people who have failed conventional treatments. I see no reason why the UK should not follow suit.

Compassionate access is a programme that permits patients with severe or life-threatening conditions—for whom standard treatments have failed and clinical trial participation is not feasible—to receive unapproved substances still in development.

In Germany, authorised by the Federal Institute for Drugs and Medical Devices (BfArM), the Central Institute of Mental Health (CIMH) in Mannheim and the OVID Clinic in Berlin are now licensed to offer psilocybin therapy to eligible patients. Led by Gerhard Gründer in collaboration with Filament Health, which will supply its psilocybin candidate, these two clinics are currently the only sites approved to provide psilocybin under this framework.

How the Programme Works

The programme emerged from years of clinical research demonstrating psilocybin’s potential for TRD, following Germany’s participation in major Phase 2 and Phase 3 studies, including the EPIsoDE trial. Approximately 20-30% of people diagnosed with depression are affected by TRD. Recognising that some patients could not access ongoing trials but faced urgent unmet medical needs, clinicians sought a pathway for legal treatment outside the traditional drug approval system. While similar psilocybin compassionate access programmes exist in Canada, Israel, and Switzerland, Germany sets itself apart by granting licensed psychiatrists the discretion to offer psilocybin on a case-by-case basis, as well as exempting approval for repeat treatments.

Eligibility & Treatment Protocol

Under the German model, patients must:

  • Have failed at least two standard antidepressant therapies.
  • Be ineligible for relevant clinical trials.

Psychiatrists at CIMH or OVID assess eligibility, oversee preparation, and supervise each dosing session. Psilocybin is administered in a controlled setting with two trained healthcare professionals, including a physician, followed by integration therapy to support psychological processing and minimise risks.

The Psilocybin-based medical product being provided is specifically Filament Health’s botanical formulation PEX010.

Crucially, the compassionate use framework operates outside the formal drug approval process and does not grant psilocybin market authorisation. Instead, it allows temporary, exceptional access under medical supervision. To improve accessibility for patients, the psilocybin itself is supplied free of charge by Filament Health, while overall treatment costs are typically covered by the patient’s health insurance. Early estimates suggest the programme can accommodate roughly 50 patients in its first year due to resource and staffing constraints, though demand is expected to be significantly higher.

 

Key Considerations

  • The compassionate use framework operates outside formal drug approval and does not grant psilocybin market authorisation.
  • Filament Health supplies psilocybin free of charge, while treatment costs are typically covered by health insurance.
  • Due to staffing constraints, the programme may only accommodate around 50 patients in its first year, though demand is expected to be far higher.

Implications for Psychiatry & Drug Policy

  1. Immediate Relief for TRD Patients – Provides an option for those with no alternatives while awaiting potential European Medicines Agency approval in coming years.
  2. Real-World Data Collection – Offers insights into psilocybin’s safety and efficacy in clinical settings.
  3. Foundation for Future Integration – Establishes clinical protocols, training pathways, and ethical guidelines for psychedelic therapies beyond trials.

By balancing compassionate access with strict oversight, Germany has created a model that offers hope while maintaining scientific rigour—a cautious yet significant step toward broader medical acceptance of psilocybin.

 

This article was written by Jody Chu and James Bunn and originally published at Drug Science UK.

Photo by Maheshkumar Painam on Unsplash.

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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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