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Calls for UK Government to pilot Overdose Prevention Centres

Public health professionals have called on the Government to take action on the record number of drug deaths in the UK.

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Calls for UK government to pilot Overdose Prevention Centres

As the UK sees a record number of drug overdose deaths, calls have been made for the Government to pilot Overdose Prevention Centres in a bid to end the national crisis. 

The Faculty of Public Health (FPH), a membership organisation of public health professionals across the UK and around the world, has led a cross-sector call for the UK Government to pilot Overdose Prevention Centres (OPCs). 

70 organisations and a number of individual signatories have made the call, stating they can “no longer accept the UK’s record number of drug-related deaths without implementing all available evidence-based interventions to save lives and protect health.”

The UK saw a record number of drug-related deaths in 2020, a total of 4,561 in England and Wales – a number up by 3.8 per cent from 2019. According to the Government’s statistics, approximately half of all 2020 drug deaths involved opiates.

See also  Novel MDMA-like chemical series to be developed to treat addiction

The call follows the Government’s announcement of a decade-long crackdown on drugs, which will see a record amount of funding to help people get treatment for their drug use. The FPH call states the plan “fails to go far enough in implementing a full public health approach as they do not include setting up Overdose Prevention Centres (OPCs).”

It continues to say: “Drug deaths are avoidable, and it is unacceptable that we see evidence-based actions to prevent harm such as OPCs go unutilised in the UK.”

Non-profit drug reform organisation, Drug Science, has signed the call along with reform organisation Release Drugs, Law Enforcement Action Partnership, the All Party Parliamentary Group for Drug Policy Reform, the Academy of Medical Royal Colleges, the British Medical Association (BMA) Board of Science and more. 

Speaking to Psychedelic Health, Drug Science CEO, David Badcock, commented: “Safer Injecting Facilities (SIFs) will save lives, and help to build a strong, trusting relationship between healthcare professionals and people with entrenched drug problems. Evidence from around the world proves this. And because of that supportive relationship, people could be helped to overcome an addiction for the very first time.

“Drug deaths have recently hit record levels. That’s why we fully support the Faculty of Public Health’s calls, and it’s why we set up the Drug Science Enhanced Harm Reduction Working Group in 2020 – to further build the evidence base and to make clear, once and for all, that SIFs are a rational, effective and humane response to an escalating crisis.”

See also  Reform organisations respond to new UK drug strategy

Last week, Drug Science responded to the Government’s new drug strategy to say it must “adopt a rational, evidence-based approach of drug control” and that other policies must be pursued in parallel of the strategy. 

This included the development and provision of new approaches to addiction treatment, including increasing research into promising alternatives such as psilocybin and ketamine, and piloting safe injection rooms, which have been proven to save lives. 

Recent research has suggested that psychedelics may hold promise in treating a variety of substance use disorders, including opioid use disorder (OUD), however, research into psychedelics in the UK is difficult due to the scheduling of the substances.

The Drug Science Medical Psychedelics Working Group has highlighted that: “…current UK regulations have created serious and considerable barriers to legitimate research associated with Schedule 1 regulations. While current legislation does not preclude scientific research with these drugs, it does make them significantly more difficult, time-consuming and costly to study.”

The FPH call highlights that there is available evidence demonstrating the effectiveness of OPCs in preventing deaths and facilitating patient referrals to treatment services, including “the adoption of safer injecting practices to reduce blood-borne virus transmission.”

The organisations state: “…we also see no evidence linking OPCs to increased drug use, criminal activity, or associated policing problems. Indeed, the House of Commons Health and Social Care Committee on drug policy, the Advisory Council on the Misuse of Drugs, the Scottish Drug Deaths Taskforce, and the Independent Working Group on Drug Consumption rooms have all recognised the clear evidence in support of Overdose Prevention Centres as an effective public health intervention.”

The Conservative Drug Policy Reform Group (CDPRG) has also joined the call.

The call concludes to sat that: “With numbers of drug deaths consistently rising for the past seven years, it is clear that current strategies to tackle this crisis are failing to deliver for populations across the UK. Unless the Government follows the evidence to take further action, we are likely to see these rates of preventable deaths continue to rise.

“With evidence supporting the effectiveness of OPCs as a harm reduction measure, we call on Government to take steps towards funding pilots on their implementation to save lives and reduce harm.”

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Policy

FDA MDMA therapy advice may be a setback, but it is not the end of the road

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FDA MDMA therapy advice may be a setback, but it is not the end of the road

An advisory body to the U.S Food and Drug Administration (FDA) has recommended against the approval of Lykos Therapeutics’ MDMA-assisted therapy – but the development is not deterring the industry.

Four months ago the psychedelics industry was abuzz when Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announced it had received FDA acceptance and priority review for a New Drug Application (NDA) concerning its MDMA-assisted therapy for PTSD.

While the final decision on the matter is not expected until 11 August 2024, the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) has delivered a major blow to the development.

The committee voted “no” on the question of whether the data shows the treatment’s effecitveness as well as on the question of whether the benefits outweigh the risks, with concerns raised over trial design, data gaps, and the potential for abuse and unethical practice.

As highlighted by Lykos, the FDA is not bound by PDAC’s guidance but it does take its advice into consideration – meaning the outcome is not looking good for the FDA’s final decision later this year.

Lykos has expressed its disappointment on the vote outcome given “the urgent unmet need in PTSD”, however, the organisation has acknowledged that the committee “faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention.”

Amy Emerson, Chief Executive Officer of Lykos Therapeutics, stated: “We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system, if approved.”

Not the end of the road

While the advisory vote may not bode well, industry stakeholders believe this is not the end of the road for MDMA-assisted psychotherapy.

With the advice concerning only the Lykos trial, there may be scope for concerns raised by the committee to be addressed in further trials, as well as other MDMA analogues or therapy designs to make it to approval.

Christian Angermayer, Founder of atai Life Sciences, believes that there is still a strong chance that, with a properly conducted Phase 3 trial, MDMA-assisted therapy will get approved.

“I (still) believe MDMA is a promising drug with tremendous therapeutic potential for patients with severe mental health issues,” wrote Angermayer.

“It isn’t MDMA itself that was rejected per se, but the specific, poor data set provided by Lykos; the committee particularly cited discrepancies in clinical trial design and conduct, inadequate collection of safety and other relevant data, bias in the evaluation of patients, and cases of patient abuse during the trials.”

Rivki Stern Youdkevich, Co-founder and CEO at Shortwave Life Sciences (SWLS), which is developing psychedelic medicines for the treatment of anorexia nervosa, has said the decision is not deterring their developments.

Youdkevich commented: “We were disappointed to learn of the panel’s recommendation but we are not discouraged.

“Mental ill health is growing at an alarming rate with an increasing number of conditions affecting more people in every age group worldwide. This necessitates novel approaches to medication and treatment, as existing therapies do not suffice. So our enthusiasm for development of psychedelics-based treatments and medicine remains undiminished.

“In fact, we are doubling down on it. Shortwave Life Sciences’ goal is to become a leader in the origination, development and operation of innovative solutions in the field of mental health. Like other psychedelics drug makers, we remain unwavering in our commitment to overcome the expected challenges on the way to approval and wide acceptance of this new field as safe, effective and viable.”

Youdkevich emphasised that the FDA’s advice will not affect Shortwave’s chances of approving its drug product for anorexia nervosa.

“Specifically at Shortwave we have several strengths in our clinical and development approach which would lead us, I believe and hope, to a positive reception,” explained Youdkevich.

“Our team of experienced clinical experts led by Dr. Nadya Lisovoder designed our clinical strategy to anticipate and meet the most stringent requirements from the regulator. We are undergoing a full set of pre-clinical studies to create a robust base of evidence and research which will illuminate our clinical trials design.

“Furthermore, our by-the-book clinical trial design will be further wisened by real-time data and learnings from our partners at the Sheba Medical Center Department of Eating disorders’ Phase 1 psilocybin-assisted therapy trial for anorexia patients.

“Our anorexia programme is based on a combination of psilocybin and additional APIs. We initially designed this combination to extend the mechanism of action of the drug, giving us flexibility in dosing of the scheduled component, psilocybin. Our drug delivery method allows for efficient administration and absorption which is currently being tested, thus maximising the effect even in a potentially lower dose of psilocybin.

“Anorexia nervosa is a life-threatening disease, with the highest mortality rate of mental health conditions and with no FDA-approved medication.

“Today, treatment for anorexia nervosa is psychotherapy based, with no standardised protocol. Our novel drug product and delivery method would naturally fit into this mode of care with the aim of achieving remission in a relatively short period, and reducing the need for years of therapy and treatment. So, although psychotherapy adds complexity to the process of regulatory approval, in our case, it is the incumbent standard of care.

“We applaud and look up to the pioneers in psychedelics drug development who are the avant-garde in creating this “new field of medicine”. They are facing head on the challenges and hurdles of evaluation and acceptance into mainstream medicine.

“Our strategy at SWLS has always been to follow in the regulatory path created by the first-comers and implement their learnings vis-a-vis the regulators. Such learning may include special attention to communication at all stages and on all aspects of trial methodology design and implementation with the regulators, to the degree trial participants are novice to the drug, as well as consideration of all aspects and the possibility of conducting blind studies with psychedelic compounds.”

MDMA is gaining global traction

While it remains to be seen if MDMA-assisted therapy will gain approval in the United States in August, the compound is gaining traction as a treatment for mental health conditions including PTSD elsewhere across the world.

Canada added MDMA-assisted therapy to its Special Access Programme in 2022 for the treatment of PTSD, and in 2023 Australia rescheduled the compound to allow authorised access to the therapy for select patients living with PTSD.

In fact, just days following the FDA’s advice, a Dutch advisory committee, which conducted a multidisciplinary analysis of the health risks of MDMA to advise the Dutch Cabinet, recommended the Government should allow access to MDMA-assisted therapy for people living with PTSD.

The independent State Commission was established by the Dutch Parliament to research the legal status of MDMA and provide advice on its medical use.

The report produced by the committee specifically advises on the pros and cons of the medicinal use of MDMA for the treatment of PTSD, advising that there appears to be sufficient scientific evidence for the effectiveness and safety of this form of therapy.

The committee has now recommended developing the medical use of MDMA for PTSD as quickly as possible, advising that regulatory frameworks are established.

In a statement, Minister Pia Dijkstra, Minister for Medical Care of the Netherlands, commented: “I am pleased that the report is now available, because it provides tools to further develop the therapeutic application of MDMA.

“Research into the therapeutic use of MDMA is promising. It is possible that MDMA as a therapy-supporting medication can help, especially for mental health patients who have been dealing with their problems for years and have not been helped by the current range of therapies.

“However, more scientific, clinical research needs to be done. With regard to the recreational use of MDMA, the report emphasises the principle of Dutch drug policy, which primarily emphasises health, prevention and reducing the harmful consequences of use, for example through monitoring and testing.

“It is therefore good that this report is now available and supports the need for substantiated policy and further scientific research.”

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

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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.

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UK advisory body issues rapid response on psychedelics for PTSD

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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.

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