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European Medicines Agency to hold psychedelics workshop in 2023

The development represents “an important next step” for psychedelics in Europe, says advocate.



EMA adds psychedelics to major depression guidelines

In response to a letter from a group of cross-party MEPs calling for the EU to act fast on psychedelics, the European Medicines Agency will be holding a multi-stakeholder workshop on the topic towards the end of 2023.

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

Signatories of the letter included MEPs Alex Agius Saliba, Robert Biedroń and Sara Cerdas of S&D, Jarosław Duda of the EPP, Tilly Metz of the Greens and European Free Alliance, and Frédérique Ries of Renew Europe.

The EMA has now responded to the MEPs in a letter signed by its Executive Director, Emer Cooke.

See also  MEPs urge European regulators to move faster on psychedelics

The letter states the EMA recognises that mental health conditions and substance use disorders are one of the highest public health challenges in Europe, and that the organisation is closely following the developments in the field of psychedelic-assisted therapies.

In light of the MEPs’ request, the organisation has confirmed it will be holding a multi-stokehold workshop later in 2023.

The letter states: “… a multi-stakeholder workshop is being planned for Q3/Q4 2023 focusing on promoting the development of psychedelics that address unmet medical needs.”

The organisation has also confirmed in the letter that it will cooperate with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) on psychedelic substances.

“I would also like to let you know that EMA has an established framework for interaction with EMCDDA, having signed the first official working arrangement already in 2010,” states the letter. 

“This Working Arrangement allows EMA and EMCDDA to cooperate and have regular exchanges at the technical level on matters falling under their respective mandates, such as exchange of information on new psychoactive substances and on abuse of medicinal products, and to develop an effective line of cooperation on psychedelic substances.”

The news has been welcomed by the MEPs, including Tilly Metz of the Greens and European Free Alliance, who commented: “I am glad to see that the EMA is keen to extend its work on psychedelics in order to better and safely ensure access to these treatments for patients in the EU.”

Tadeusz Hawrot, Founder and Executive Director of Psychedelic Access and Research European Alliance (PAREA), which will be working alongside the MEPs on the matter, and which last year invited the EMA to consider organising an EU-led workshop on psychedelics, also welcomed the development.

Hawrot told Psychedelic Health: “We are grateful for the impartial support that EMA has consistently demonstrated towards this field, establishing itself as an institutional champion that remains acutely attuned to the cutting-edge advancements in the realm of psychedelic therapies and the immense promise they hold for millions of Europeans.

See also  EU bodies provide perspective on regulation of psychedelics

“Personally, I’m thrilled by the announcement of a multistakeholder workshop. I’m convinced that an EU-led workshop involving actors like relevant EU institutions, member states’ representatives, patients’ organizations, and scientists will represent an important next step. 

“It can initiate a multilateral reflection process, paving the way for Europe to prepare for the arrival of novel psychedelic treatments and exploring the potential role that EU institutions, such as the European Commission, could play in it. This could take a form of an EU-led action laying strong foundations for the rollout of those novel treatments by establishing European quality guidelines that EU Member States could choose to follow as they put in place frameworks and structures to accommodate the medical use of psychedelics.

“By engaging now, we can ensure that psychedelic treatments are not prematurely introduced into clinical practice without robust regulation and preparations aiming to safeguard people’s health and long-term sustainability of psychedelic medicines. 

“We are facing a unique opportunity to develop expertise and infrastructure to ensure the highest quality, safe, affordable, and equitable access to psychedelic therapies. Ultimately, this will enable us to help the greatest number of people benefit from the transformative potential of these treatments.”

See also  PAREA 2023: campaigning for psychedelic therapy in Europe 

The EMA highlights that there are 11 ongoing clinical trials in the EU with psilocybin, four trials ongoing with MDMA and one trial with LSD. 

In the letter, the organisation also confirms that the EMA and members of its Central Nervous System Working Party are actively engaged with academic researchers from the European College of Neuropsychopharmacology (ECNP). 

“This close cooperation has resulted in a recent publication in The Lancet articulating the European regulatory and scientific challenges related to the topics, and an encouragement for all developers (academic and industry) to engage with EU regulators,” stated the EMA.

The EMA and members of the Central Nervous System Working Party will be holding a session at the ECNP New Frontiers Conference on psychedelics from 19 to 20 March 2023.

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Canada recommends launch of Veterans psychedelic research programme



Canada launch Veterans psychedelic research programme

A new report has been released by Canada’s Senate Subcommittee on Veterans Affairs – ‘The Time Is Now: Granting Equitable Access to Psychedelic Assisted Therapies’ – which recommends the launch of a large-scale research programme on psychedelics for Veterans’ mental health.

Emphasising that around 10 to 15% of Canadian veterans are diagnosed with post-traumatic stress disorder (PTSD), the report explores the opportunity presented by psychedelic research as a treatment for alleviating symptoms of the condition.

The Subcommittee suggests the programme should be funded by Veterans Affairs Canada (VAC) and the Department of National Defence (DND) in partnership with Health Canada, the Canadian Institutes of Health Research, and other relevant partners.

The report states: “This approach would ensure, first of all, that those veterans most likely to benefit from it are given access to treatment with the best scientific support available, and second of all, that the initial findings on the effectiveness of this treatment for veterans are either proven or qualified.”

And goes on to say: “It is the Government of Canada’s duty to assure veterans that it is doing everything in its power, immediately, to respect its solemn commitment to support, at any cost, those who chose to defend us with honour.”

Psilocybin and MDMA have already been added to Canada’s Special Access Program (SAP) which enables authorised patients to access psilocybin and MDMA-assisted therapy for conditions such as PTSD and end-of-life anxiety. 

Studies are showing that both psilocybin-assisted therapy and MDMA-assisted therapy could be potentially efficacious treatments for alleviating symptoms of PTSD in Veterans.

However, the report notes that most clinical studies involve the general population and that Veterans often respond differently to treatments, highlighting the need for further research in the Veteran population.

The report and recommendation have been welcomed by the Psychedelic Association of Canada (PAC), which works with lawmakers, healthcare workers, educators and researchers, psychedelic practitioners, businesses and the public to gain access to psychedelic medicines for Canadians.

Jay Katz, Executive Director of the Psychedelic Association of Canada, stated: “The PAC is encouraged by the contents of the Senate Subcommittee’s report. Their acknowledgement of the potential inherent in reshaping our approach to treating mental illness is an auspicious first step. It paves the way for significantly improved outcomes.”

The organisation has highlighted that, in light of growing research, Canadian citizens have demonstrated strong support for increased access to psychedelic medicines.

To read the full report please visit:

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PAREA’s psychedelic push: improving policy for mental health innovation in Europe



Medical psychedelics policy paper launched in Europe

The Psychedelic Access and Research European Alliance (PAREA) has launched a policy paper in line with a recent meeting on medical psychedelics in the European Parliament. 

In a significant step for Europe, the MEP Action Group for the Medical Use of Psychedelics meeting took place to dicuss medical psychedelics within the EU pharmaceutical legislation framework.

PAREA launched its policy paper “Unmet Medical Needs: Aligning Medical Innovation with Societal Health Needs” in line with the event, and as a follow up to the orgainsation’s recent position statement, “Leveraging the EU Pharmaceutical Package: A Life Cycle Approach to Address High Unmet Needs and Foster Mental Health Innovation by Incentivizing Psychedelic Novel Medicines”.

See also  PAREA launches psychedelics manifesto for mental health in Europe

Challenging the current paradigm that narrowly defines unmet and high unmet medical needs, PAREA argues in the policy paper that “the existing focus on life-threatening or severely debilitating conditions fails to consider the broader health and societal context.”

The paper outlines the burden created by prevalent mental health conditions including on the individual as well as healthcare systems, society and the economy, arguing that “the current criteria for unmet medical needs do not adequately account for the potential to significantly improve quality of life, especially for chronic conditions.”

As this criteria dictates what receives funding, the paper argues, “a recalibration is essential for ensuring that medicine development aligns more closely with public health priorities and needs.”

The policy paper also calls for:

  • The urgent expansion of criteria used to define high unmet medical needs to include the prevalence of conditions and their societal impact.
  • The establishment of a European Hub for Mental Health Research and Development that would unite EU institutions, member states, healthcare funders, and philanthropic organizations. 
  • For mental health to be addressed as a central pillar of sustainable development.

On the European Parliament meeting, PAREA stated: “The event, which coincided with the ongoing discussions on the revision of the EU pharma package, focused on creating a supportive regulatory environment to foster innovation in novel mental health treatments, particularly psychedelic therapies.

“The gathering underscored the urgency of addressing unmet medical needs in the EU and the potential of psychedelic therapies to offer rapid, durable improvements for conditions such as depression and PTSD.”

The organisation continued: “As the EU revises its pharmaceutical legislation, PAREA’s policy paper serves as a critical voice, advocating for a recalibrated approach that aligns medicine development with public health priorities and societal needs. It is a call to action for policymakers, healthcare professionals, and stakeholders across Europe to recognise and address the unmet needs in mental health care.”

To read the full policy paper please click here.

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Study to investigate psilocybin therapy for cancer-related depression



Study investigate psilocybin therapy for cancer-related depression

Psychedelic therapy company Sunstone Therapies has announced the start of its first study investigating multiple doses of psilocybin in the treatment of major depression disorder (MDD) in patients with cancer. 

The Phase 2 two-part study, taking place at the Bill Richards Center for Healing at the Aquilino Cancer Center, will examine the safety and efficacy of up to two 25mg doses of psilocybin in 56 patients administered at an interval of 9 to 10 weeks.

The first part of the study will administer a first dose of psilocybin in a double-blind, randomized, placebo-controlled portion, while the second part of the study will take the form of an open-label portion for patients who do not achieve MDD symptom remission after the first dose.

All study participants will be supported through the first dosing sessions by a study therapist in addition to a second therapist monitoring via video feed, and in the second session, all eligible participants will receive psilocybin 25 mg in an open-label fashion using a group session model.

Chief Medical Officer at Sunstone Therapies and Principal Investigator on the study, Paul Thambi MD, commented: “The emotional distress associated with cancer is often as significant as the physical effects, and yet oncologists have few effective treatments to tackle this important aspect of the patient experience. 

“More recently, the use of psychedelic-assisted therapy has seen renewed interest and a number of studies show a positive impact on symptoms of depression in patients with cancer, including our own open label study published in JAMA Oncology. 

“This new study includes a placebo control arm, the use of group administration, and – for the first time – multiple doses. We believe this adds significantly to the understanding of the role psilocybin-assisted therapy could play in improving patients’ lives and how it might best be delivered.”

Chief Executive Officer at Sunstone Therapies, and Clinical Investigator on the study, Manish Agrawal MD, added: “The Sunstone team has a longstanding commitment to advancing clinical research in psychedelic-assisted therapy in cancer patients, and unique depth of experience across psychedelic modalities and indications. 

“This study builds on our pioneering approach to clinical trial design: there is limited data addressing the question of whether multiple administrations of treatment doses of psilocybin in patients with cancer lead to improved efficacy. 

“We look forward to making a further contribution to the clinical development of this potentially vitally important treatment modality.”

The primary efficacy endpoint of the study is the change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 8, and secondary endpoints – which include the onset and durability of response, response rate and remission, and the effect on pain – will be used to assess parameters in both the placebo-controlled and open label study conditions.

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