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Colorado to vote on natural medicine bill to decriminalise psychedelics

The Natural Medicines Health Act has recently seen opposition from a number of officials and organisations.

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On November 8, 2022, Colorado citizens will be casting their vote on the Natural Medicine Health Act 2022 which proposes to decriminalise and regulate the use of psychedelic medicines. 

Colorado’s Natural Medicine Health Act (Proposition 122) recognises the failure of the state’s current approach to mental health, noting that citizens need more tools to address such issues. It suggests that new approaches to mental health should be grounded in treatment, recovery, health and wellness rather than “criminalisation, stigma, suffering and punishment”.

Following suit from Oregon, which became the first state in the US to approve of legalised psilocybin under Oregon’s Psilocybin Services Act – “Measure 109” – in November 2020, Colorado’s bill recognises the extensive growing body of evidence suggesting that psychedelic therapies could hold promise as treatments for mental ill health.

See also  What psychedelics has got right that the cannabis industry hasn’t

“The Federal Government will take years to act and Coloradans deserve the right to access natural medicines now,” states the Bill.

“Natural medicines” are defined in the bill as including DMT, ibogaine, psilocybin/psilocin and mescaline (excluding peyote), however, until June 2026, this definition will only include psilocybin and psilocin.

What does the bill propose? 

With an aim to establish a compassionate and effective approach to natural medicines, the bill proposes a variety of measures that would ensure the safe delivery of care to patients, with a focus on harm reduction and improving education.

Harm reduction initiatives would include the removal of criminal penalties for people over the age of 21, and education would be focused around public service campaigns, public service announcements, educational curricula and training for law enforcement and first responders. 

If passed, a Natural Medicine Advisory Board will be established that will advise on the implementation of the bill, which will see the launch of a medical access programme. The programme will regulate the cultivation, manufacture, testing, storage, transfer, transport, delivery, sale and purchase of psychedelic medicines.  

By January 2024, rules will be established for the qualifications, education and training requirements for psychedelic facilitators that deliver medicine to patients. 

Healing centres – licensed entities that deal with natural medicines – will be permitted to provide services where participants can consume, but also to refuse to provide services to an individual. Any one individual would also be prohibited from having financial interests in more than five healing centres.

As well as protecting citizens from legal punishment through the removal of penalties, licence holders would also be protected from legal punishment within Colorado. 

Rules will be established regarding dosing recommendations, equitable and inclusive access to services, licensing, health and safety, supervision of sessions, provisions for group administrations and testing of medicines, among others. 

What are the chances of success?

Nearly 50 million Americans are living with a mental health condition. For those living with a condition such as major depressive disorder (MDD), just over 30% are resistant to current treatments, revealing a desperate need for innovative approaches to mental health care. 

As recognised in the act, psychedelics have shown promise for treating a variety of mental health-related conditions such as depression, anxiety, post-traumatic stress disorder (PTSD) and addiction. 

Natural Medicine Colorado, an organisation that is sponsoring the initiative, states the bill is designed to “create regulated access that maximises safety to natural psychedelic medicines for veterans struggling with PTSD, people facing a terminal illness, and adults dealing with depression, anxiety and other mental health challenges.”

A recent survey carried out by Verywell Mind revealed that half of Americans support the use of psychedelics as mental health treatments, suggesting the sentiment may be positive towards the bill. 

However, the most recent developments have seen 30 officials urging citizens to vote against the bill, stating it is too early to know the effectiveness of the medicines for mental health. 

The Rocky Mountain State Area Conference of the NAACP, drug reform group Blue Rising, the Mayor of Denver Michael Hancock and Attorney General Phil Weiser, among others, have signed the letter.

The signatories state: “The multi-million dollar campaign to promote Prop 122 is not backed by benevolent Coloradans who are concerned about our mental health crisis. In reality, these out-of-state corporate actors are seeking to benefit financially by making Colorado a new target market for unregulated psychedelic drugs that science has yet to prove are safe or effective. 

“This ballot measure is not a solution to our mental health crisis. It could make things exponentially worse.”

Also signing the letter is the Native Coalition Against the Natural Medicine Health Act – a collective of intertribal Indigenous Native American people.

The coalition states that the bill stands to threaten, exploit and commercialise Indigenous peoples and spiritual traditions. 

The coalition states: “It ignores critical issues pertaining to stewardship, conservation, intellectual property and fair-trade practices. This bill misleads and falsely informs the public. The bill is opposed due to the rampant neglect, abuse and harm that has already occurred within psychedelic research. 

“Further, it is opposed because the bill’s co-authors have positioned themselves to profit from the legalising and medicalising of natural medicines to the exclusion of the greater community. It lacks inclusion of disproportionately impacted communities. 

“The passing of Proposition 122 positions these natural medicines for extractivism, some of which are not Indigenous to Colorado, by those with limited understanding and knowledge of the medicines and their applications, which will ultimately create further inequities, criminalising and desecration of the sacred.”

To read the Natural Medicine Health Act of 2022 in full please visit: https://www.sos.state.co.us/pubs/elections/Initiatives/titleBoard/filings/2021-2022/58Final.pdf 

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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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