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.”
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.
Italian campaign on psychotropic substances has signatures verified
Co-founder and international co-ordinator Associazione Luca Coscioni shares his thoughts on the outlook for the campaign.
Signatures for an Italian campaign calling for the decriminalisation of psychotropic substance cultivation have now been verified by officials.
In 2021, the campaign gathered the half a million signatures needed to trigger a referendum in less than a week. All of those signatures needed to be verified as Italian citizens in order to progress to a referendum.
With the signatures now verified, one more step remains until a referendum can be called in the spring.
The campaign has focused on cannabis but pertains to the cultivation of all psychotropic substances, such as mushrooms and peyote.
It has been spearheaded by Forum Droghe, Meglio Legale, Antigone, Luca Coscioni Associations, Società della Reagione, and is supported by parties Volt Italia, Possible, Italian + Europa, and the Communist Refoundation.
Speaking to Psychedelic Health, Marco Perduca, co-founder and international co-ordinator at Associazione Luca Coscioni, which supports freedom of scientific research, commented: “I think this confirms the good idea we had in August, which was that there’s so much popularity concerning the need to amend the drug laws – in particular concerning cannabis – that the moment in which a lot of people would have been allowed to do something very quickly to support the referendum, they would have done it.
“We collected the necessary 500,000 signatures in less than a week and the remaining 30,000 signatures in the additional 10 days. According to the law, it’s not only necessary to submit signatures, you have to document that those who signed are certified registered voters in Italy.
“This is why it took two and a half months to count. This is the first step.”
The campaign aims to modify the wording of “cultivation” in the Consolidated Law on the Discipline of Narcotic Drugs and Psychotropic Substances in Presidential Decree 309/1990.
“The second step is that a title is offered for the referendum – which, according to our reading, was a little too strict on the words that we were eliminating,” said Perduca.
“So, we found a compromise solution in which, despite the fact that the word “cannabis” will not appear in the text nor in the title, at least the conduct of cultivation, sharing and personal use are represented in the title.
“The law is very complicated to amend. You cannot just take away a plant or a substance from the schedule. You have also to find other parts of the law that should be eliminated because what is penalised is the action of the plant, per se.
“So, according to our reading not only of the law but also of the jurisprudence of previous decisions of the Constitutional Court that have blocked similar referenda proposals in 1997 – we decided to go this way. But at least it is clear that it’s a referendum about cultivation and the personnel use and sharing of so-called “soft drugs”.”
Perduca highlighted that the camping is now working on a document that will be presented by two lawyers before the Constitutional Court on February 15 together with seven other referenda.
“This document will touch upon issues such as the international implications of the deletion of the parts of the law and the constitutional requirements of Article 75 that prohibits the submission of referendum on issues – changes to the constitution, changes in the fiscal system, but also changes in laws that have enacted international treaties.
“And there could be a doubt here that we are in fact, working to do that. We are not because we are just eliminating some words, so we are not un-ratifying a document.
“The law we are working on has never been considered an implementing instrument of the 1988 Convention on drugs. And the third part is the penal part because of course, taking away criminal sentences we have to give as satisfying arguments that the law after the elimination of the words of the referendum is an immediately applicable law.”
The Constitutional Court has until 10 March 2022 to make its decision public.
Perduca highlights that Italy is currently in a critical political situation, as, due to a new agreement that on 24 January 2021, the Parliament must elect the new president of the republic.
“If the current head of government is going to be elected president of the Republic, there is going either going to be a reshuffling in government or – and this will pose a huge problem for the referendum – if they won’t sign an agreement there is going to be early elections.
“The referendum will push to 2023 because our law doesn’t allow us to have political elections and referenda at the same time.”
If early elections do not happen – Perduca says the campaign will request a vote on the referendum to take place on the same day of administered municipal elections at the beginning of June.
“The major obstacle now will be to reach the quorum which is 50 per cent of the population plus one vote. We are talking about 27 to 28 million people beyond the age of 18 to turn out and vote.
“The other important political element to take into consideration is that there’s going to be eight referenda before Constitutional Court on 15 February.
“As well as this campaign, there will be one euthanasia which is also co-promoted by the Lucas Sione Association, which collected twice as many signatures as this one. So, legalisation of euthanasia is a hugely popular theme, but the other six have been promoted by the parties belonging to the center-right coalition, who are all opposing the other two referendums. So, if there is this synergy between those that will ask their voters to go and vote yes for their six and at the same time vote no to the other two.
“We are counting on people to show up because we know both euthanasia and cannabis are so hugely popular. There’s absolutely no discussion that we’re going to win if there’s going to be a quorum. And so in the event in which all a referendum we will put to a vote.
“There is some hope that the turnout will be significant. If the Constitutional Court will say no to either all six or to some of the most politically charged of the six referendum concerning the reform of the administration of justice in Italy, things will turn out in a different way.
“We are ready to fight our battle.”
Global coalition launches to push for psilocybin rescheduling
Today marks the launch of the International Therapeutic Psilocybin Rescheduling Initiative.
The International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) has launched today to push for the rescheduling of psilocybin across the globe.
For more than 50 years psilocybin has been placed under Schedule 1 of the 1971 UN Convention on Psychotropic Substances in most countries across the world.
Now, the new ITPRI global coalition initiative will be working to promote and secure the rescheduling of psilocybin under the Act.
The 1971 UN Convention on Psychotropic Substances Act is aimed at dangerous drugs which create a serious risk to public health and which have a therapeutic value of little to none. This limits their scientific and medical use much more strictly than other Schedules.
In recent years, however, evidence of the therapeutic potential of psilocybin has been emerging for mental health conditions including depression and anxiety, as well as end-of-life distress and addiction.
According to professor David Nutt, head of Imperial College London’s Centre for Psychedelic Research and founder of ITPRI partner Drug Science: “Psilocybin’s Schedule I status has severely limited – and continues to limit – neuroscience research and the development of treatments for patients.”
As a result of psilocybin being classed in Schedule I, researchers face numerous regulatory hurdles to study the compounds, which add significantly to the cost, complexity, and duration of research and can negatively impact ethical approvals, funding and collaboration.
The need for a scheduling review
The ITPRI will be working with governments and institutions across the globe through engagement, education and mobilisation to advocate for a more sensible policy that enables scientific and health research into psilocybin.
Speaking to Psychedelic Health, Christopher Koddermann, ITPRI co-founder and chair of the board of directors, commented: “We think this is the right time to pursue this.
“The goals of the 1971 convention are to balance two things: to “combat abuse” is the term they use, and, to ensure that scientific and medical availability is not unduly restrictive.
“It is pretty clear that they have got that balance wrong when it comes to psychedelics. The decision to schedule psilocybin, and frankly, other psychedelics in Schedule 1 is a result of largely political factors.
“They did not do any assessment in terms of therapeutic potential. They did not do any assessment in terms of non-medical use and dependence, and they have never done it – it has never been done at the international level.
“So, we are stuck with a scheduling decision that was made in the early 1970s and it has never been really looked at.”
The potential for new mental health treatments
There are currently hundreds of millions of people across the globe living with mental health conditions, and there has been no innovation in treatments since the advent of SSRIs – which do not work for many. This situation has also been exasperated by the COVID-19 crisis.
“There has been a huge focus on mental illness as a result of COVID due to what it has done in the US and the UK, and elsewhere, in terms of the rates of depression, anxiety and other mental health conditions,” said Koddermann.
WHO statistics show that mental health conditions are the leading cause of disability-adjusted life years lost, accounting for 37 per cent of healthy life years lost from non-communicable diseases.
Researchers have suggested that psychedelics could help to provide desperately needed new treatments for mental health conditions.
Willem Scholten, ITPRI Advisory Board member and former Secretary to the World Health Organization (WHO) Expert Committee on Drug Dependence (ECDD), the body responsible for international drug control scheduling recommendations, commented: “Rescheduling procedures under the 1971 Convention offer a potentially game-changing opportunity to advance further research and accelerate the approval of treatments for patients.”
Pursuing change for science and health
The ITRPI will pursue the schedule change, basing its objectives on research from a number of leading universities and institutes.
Its ultimate goal is to accelerate research and foster the availability of psilocybin-assisted therapies for those suffering from mental illness and substance use disorder.
Partner organisations in the effort include leading psychedelic research, drug reform and human rights organisations such as The Beckley Foundation, Drug Science, the Multidisciplinary Association for Psychedelic Studies (MAPS), Mind Medicine Australia, Nierika AC, the Open Foundation and the Osmond Foundation.
“In 2010, the WHO Executive Board adopted guidance for the ECDD as it undertakes reviews. One of the things that guidance states is that recommendations for inclusion in Schedule 1 should only be made when criteria are fully met with respect to both therapeutic usefulness and public health,” said Koddermann.
“In other words, you do not put a compound in Schedule 1 unless you have both — especially serious risk to public health, and very limited if any, therapeutic usefulness.
“Anybody who is involved in psychedelic research and science would tell you that psilocybin doesn’t tick either box, let alone both boxes. So, it is clearly prime for rescheduling.
“Presuming the ECDD look the evidence in an impartial manner and follow the science, one could anticipate a recommendation out of the ECDD to change the Schedule.”
Scheduling decisions are made by the UN Commission on Narcotic Drugs (CND), and formal scheduling reviews may be initiated either by the WHO or by notification by any State party to the 1971 treaty. The ECDD is tasked with making scheduling recommendations based on a medical and scientific review of the compound in question.
If a review of psilocybin is undertaken by the WHO and scheduling recommendation is provided, the CND may decide to add, transfer or remove the substance from Schedule 1. This must be by a vote of a two-thirds majority. However, the CND must accept the findings of the WHO and is not able to base its decision on other medical or scientific views.
The ITPRI has highlighted that a recent precedent exists for such a review and rescheduling of drugs under the UN drug treaties, as, in 2020, the CND voted to accept a WHO recommendation to remove cannabis and cannabis resin from Schedule IV of the 1961 Single Convention on Narcotic Drugs.
To achieve its aim in securing the rescheduling of psilocybin, the ITPRI will be pursuing three parallel routes including a WHO-initiated scheduling review, a state party-initiated scheduling review and an ECDD pre-review leading to a formal critical review.
Koddermann concluded: “Given today’s scientific understanding of psilocybin’s high potential therapeutic value and low risk of dependence, a change of its status as a Schedule I drug is long overdue.”
For more information, please visit www.reschedulepsilocybin.org.
Canada’s amendment allowing patients access to psychedelics welcomed
Authorised patients will now be able to access psychedelics through the country’s Special Access Program, marking “greater change to come”.
The Canadian Government has amended regulation in order to allow patients to access psychedelic medicines such as psilocybin and MDMA.
Canada’s Special Access Program (SAP) will now enable physicians the right to request access to psychedelic-assisted psychotherapy for patients, which will be reviewed on a case-by-case basis.
The Canadian psychedelics industry has welcomed the news as a positive development for patients, noting that it will prevent psychedelic medicines following the path of cannabis – which has ended up with a lack of clinical research – and that it recognises the growing evidence base supporting the efficacy of psychedelics.
Published in the government’s official newspaper, the Canada Gazette, the regulation amendments relate to the Controlled Drugs and Substances Act and the Food and Drugs Act.
The amendments are expected to benefit patients with serious or life-threatening conditions, says the government. Patients will be granted this access when “other therapies have failed, are unsuitable, or are unavailable in Canada.”
The change is a response to requests to remove restrictions on the compounds as evidence has been emerging in recent years regarding the therapeutic potential of psychedelic medicines.
In particular, substances such as psilocybin and MDMA have been granted Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) for conditions such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD).
Implementation of the amendments was confirmed after a 60-day consultation with healthcare professionals, organisations, researchers, academics, licensed dealers and the general public regarding the government’s intent to restore access to these restricted drugs. It has stated it received written feedback from 392 respondents.
In the publication, the government says: “Overall, nearly all comments were supportive of the proposed regulatory amendments and/or increasing access to psychedelic substances more broadly.
“The Department received very little opposition to the proposal, making up less than 2 per cent of all responses.”
Kelsey Ramsden, CEO of Vancouver-based MINDCURE, which is carrying out a first-of-its-kind study investigating MDMA-assisted psychotherapy for treating female Hypoactive Sexual Desire Disorder (HSDD), commented: “For emergency patients, this news means gaining access to life changing mental health care. This can be truly transformative for both the patient in their ability to live out their last days, as well as for their families and supporting communities.
“For MINDCURE, it confirms that leaders in Federal Health Policy acknowledge the promise of psychedelics. Assuming they will stay strong with implementing the emergency-only approvals, it confirms that we will not be going down the slippery slope of recreational use that cannabis saw, which resulted (for cannabis) in a lack of funding for true drug development and clinical research.
“The balance between keeping clinical trials as the only regulatory route to market with a very small number of emergency access cases will be pivotal. I am confident that emergency-only will be maintained.
“Health Canada is open to psychedelics, and they want to see the clinical research proof come out to support widespread use. This means those of us conducting clinical research programmes are in the best position to be able to develop drugs that will change the paradigm of care in mental health.”
“Reversing the prohibition on accessing restricted drugs does not guarantee that requests for psychedelic restricted medicines will be authorised through the Special Access Programme,” commented Dr Evan Wood, CMO at Vancouver-based Numinus Wellness, which is hosting an extension of the MAPS-sponsored trial exploring MDMA-assisted therapy for PTSD.
“All requests will continue to be assessed on a case-by-case basis, taking into consideration the level of evidence regarding the safety and efficacy for the proposed use, as well as the patient’s condition and their clinical status.
“Numinus will be working closely with Health Canada to understand the regulatory change and, where appropriate, support appropriate SAP requests. We are currently operating clinics with appropriately established psychedelic-assisted psychotherapy infrastructure and trained therapists and physicians to support patients with special access requests.
“We are closely following updates from Health Canada on the SAP amendment and will follow their guidance and regulations consistent with the updated SAP Guidance document. We are well positioned to support our affiliated physicians and clients with SAP requests.
“Numinus believes this is only the beginning of greater change to come, it signifies an important step towards creating expanded safe access to treatment and care in the mental health sector through psychedelic-assisted psychotherapy.
“Greater accessibility is something Numinus has stood behind since we started and will continue to support and advocate for.”
Dr Douglas Cook, CMO at Dimensions and chairperson and head of neurosurgery at Queen’s University, Kingston, Ontario, stated: “Patients in urgent and life threatening circumstances who have failed to improve with traditional therapies will have the SAP as an option to access psychedelic therapies that are showing promise in palliative care and in a number of mental health indications.”
Dimensions carries out psychedelic-assisted therapy programmes supported by neuroscientific research.
“The application will be submitted on behalf of the patient by a physician who will summarise the need and justification for treatment. The turn around time is rapid and once approved a patient will be able to source medicine from a licensed dealer. This process is a welcome option to help those in dire need of options for otherwise unresponsive diseases.
“Dimensions firmly believes that psychedelics have the potential to alleviate suffering for a number of mental health and medical indications. We further believe that psychedelic therapy is optimally delivered in a safe, comfortable setting with trained professionals to set intentions of therapy, guide the experience and follow up after.
“To this end, Dimensions is looking forward to the opportunity to host individuals who have obtained psychedelics through the SAP in retreat and ceremony. Our goal will be to provide groups of patients with common diagnoses and intentions in retreat. Furthermore, our medical team will be able to assist patients, in partnership with their primary caregivers, in obtaining SAP approval.
“Dimensions lauds Health Canada for opening the SAP program for psychedelic therapies. This decision recognises the growing evidence base supporting the efficacy of psychedelics in end-of-life care and for several mental health and medical indications.
“Moving forward Dimensions will continue to support rigorous science and strong regulatory oversight in completing clinical trials and preclinical studies to further define the mechanisms, safety and efficacy of psychedelics for various indications.”
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