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Psychedelics industrial complex could put psychedelic religions in jeopardy

The Oregon Psilocybin Committee is considering special protections for the religious use of psilocybin after warnings that the industry could endanger psychedelic religions.



Psychedelics industrial complex could put psychedelic religions in jeopardy

A subcommittee of the Oregon Psilocybin Advisory Board (OPAB) is considering whether to provide special protections for religious practises involving the use of psilocybin.

The OPAB has been warned that the rise of a new psychedelics industrial complex could put psychedelic religions in jeopardy if Oregon fails to act quickly.

Attorney Jon Dennis of Sagebrush Law, warned the board that the industry has already begun engaging in aggressive tactics to prevent newcomers from entering into the industry, despite psychedelics not yet being legal at a state or federal level.

Although the US Supreme Court has already approved of granting religious liberties to churches that use psychedelic plants as sacraments, Oregon is the first state to decide the scope of freedoms for psychedelic religions through administrative regulation.

Measure 109

Oregon has one of the highest prevalences of mental illness in the nation, affecting one in every five adults. With the rise in promising results regarding the efficacy of psilocybin for mental health conditions, Oregon became the first state in the US to approve of legalised psilocybin under Oregon’s Psilocybin Services Act – “Measure 109” – in November 2020.

Measure 109 aims to develop a “long-term strategic plan for ensuring that psilocybin services will become and remain a safe, accessible and affordable therapeutic option for all persons 21 years of age…” and “establish a comprehensive regulatory framework concerning psilocybin products and psilocybin services under state law…” among other actions.

In a meeting with the OPAB, Dennis presented a set of draft regulations that would grant religious protections under Oregon’s new psilocybin law.

See also  Global coalition launches to push for psilocybin rescheduling 

Addressing the board, Dennis cited the words of medicine woman Maria Sabina, whose sacred ceremonies in Mexico were based on the use of psilocybin. When the news of her ceremonies broke in The Times, Westerners flocked to Mexico in order to experience the mushrooms. This led to restrictions from the Mexican Government on their ritual use.

“Never, as far as I remember, were the saint children [the mushrooms] eaten with such lack of respect,” Sabina had commented – saying that foreign visitors ruined the purity of the mushrooms.

Dennis commented: “When we think about what Oregon is doing right now with this new psychedelic programme, we have to consider this history – part of this history is the emergence of the psychedelics industrial complex. This is the list of companies that are publicly traded.

“Keep in mind – with about $4.8bn in market cap – non of this is really legal yet. I don’t suppose that all of these companies are engaging in aggressive tactics – but we are already starting to see the intellectual property grabs and the land grabs, to corner out other types of access to psychedelic healing modalities that exist. 

“If we as a society are to protect religious use the best way to do that is to do it now. Because as these companies get bigger and bigger and become more aggressive, and try to corner out other types of psychedelic healing and psychedelic use, it is not going to get easier as this psychedelic complex gets more entrenched.”

Concerns were also raised regarding lobbyists meddling in Oregon’s psilocybin programme.

Protections for entheogenic practitioners

Many people across the world use entheogens – psychoactive plants or substances that are used in a sacred or spiritual manner.

To reflect this use of psychoactive plants, within Dennis’ draft framework, the word “entheogenic” is used rather than “religious” to ensure that those who use these plants as part of any practice related to their sincere beliefs have their rights maintained. 

See also  Could Italy decriminalise psychotropic substance cultivation? 

Dennis proposed a partnership between the Oregon Health Authority and entheogenic practitioners that he believes would be beneficial to all parties, by bringing entheogenic practice out of the underground to “above ground”. This would provide oversight and accountability, ensuring that people are going through a screening process and safeguards are in place. It will also ensure practitioners will not have to face the risk of jail for practices related to their beliefs.

“This also helps with the tension inherent in Measure 109 around accessibility and affordability,” said Dennis. “I believe, particularly with the peer support model and homegrown mushroom model, that we can drive the price point down to something that is actually affordable.

“This cause is too important for it to be another vehicle to reinforce or deepen inequalities that exist along racial, health or financial mechanisms – it is going to be such a tragic thing as we enter into this new era where we re-establish relationships with plant medicines – it is critical we give small community-led organisations their own means of production and do something to protect that.”

Click here to read the draft framework

Community-based healing

Bob Otis Stanley, pastor and chief garden steward of Oakland-based church, the Sacred Garden Community, which uses psychedelic plants as part of their religious ritual, also highlighted the importance of community-based healing.

Stanley commented: “We have a common faith in our church that the sacraments of our church are approached with care, respect and trust and can connect us with experience of divine presence within this lifetime. 

“But we can accept many incoming faiths – atheism, Christian, Jewish, Islam, Pagan. So, we are trying to create a strong container for the diversity that we find here in Oakland, but also who have a sincerely shared faith. 

“By trying to create this community framework that has deliberate harm reduction built-in we are recreating some of the benefits in long term culture that I have experienced in the many years visiting the Sierra Mazateca region. Each little village and valley that will have one or two, or several, curanderos [healers] will have culture integrated with that healing process – we are lacking here in the United States. 

“So to have an intentionally created community that can provide some of that support for the frameworks you may find in other traditional cultures is part of our goal.”

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Markets & Industry

Shortwave Life Sciences hits major milestone with positive patent claim



Shortwave Life Sciences, previously Psych Capital, has received a positive patent report from the PCT confirming its mucoadhesive buccal film as a novel and inventive drug delivery platform for psychedelic-based drugs.

Shortwave Life Sciences (PSY:Aquis AQSE) is working to transform Anorexia nervosa care through innovative approaches and treatments, including psychedelics.

Anorexia nervosa is a complex mental health condition as well as a metabolic disease, with one of the highest fatality rates. However, there is currently no FDA-approved pharmacological treatment for the condition, underlining an urgent need for innovation in this area.

To tackle this challenge, Shortwave Life Sciences has developed a novel drug based on psilocybin and another API, which Shortwave says provides an expanded mechanism of action and a therapeutic effect superior to psilocybin alone, impacting more than one group of receptors in the brain.

See also  Psych Capital completes acquisition of Short Wave Pharma

The company has developed its novel delivery method in the form of a buccal film. This method of administration is designed to be sensitive to patient needs, who may not want to swallow the medicine, and also provides higher bioavailability.

Positive patent report

Shortwave recently received its positive report from the PCT examining authority acknowledging all of its claims regarding its buccal film as novel, non-obvious and industrially applicable, marking a major milestone for the company.

Rivki Stern Youdkevich, CEO of Shortwave Life Sciences, commented: “This acknowledgement by the PCT committee is very important for us as we progress in our drug development path.

“The PCT’s examining committee’s report acknowledging all our claims as free of prior art confirms our belief in our patient-focused IP and drug development strategy. As we move to the national phase, we are reaffirmed in our mission of pioneering breakthrough therapies that transform the landscape of mental health care, especially psychedelics-based.”

With this IP confirmation, Shortwave has confirmed it can now begin to utilise its buccal film delivery platform, which is currently in clinical testing, in administering additional drug combinations including under licensing agreements with future potential partners.

Stern Youdkevich continued: “Our Buccal film, which is a topical route of administration applied in the cheek, allows our psilocybin-based drug combination to diffuse through the oral mucosa and enter directly into the bloodstream, providing better bioavailability and more rapid onset of action compared to oral administration because the medication does not pass through the digestive system and thereby avoids first-pass metabolism.

“We believe this can be extremely beneficial for anorexia nervosa patients who experience severe metabolism-related challenges. We are very excited to study this further in our upcoming clinical trials coming up.”

The company has stated that it is aiming for a rapid approval process through the FDA pathway for approval.

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Study identifies MDMA variants that could make therapy safer



Study identifies MDMA variants that could make therapy safer

A new study from MedUni Vienna has identified three new variants of MDMA as promising alternatives for safer use in a controlled psychotherapeutic setting.

The recent blow to MDMA therapy from the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) has put a dampener on many people’s hopes that the treatment would be approved this August.

While that still may happen, one of the major concerns of the advisory body was the compound’s safety data, and the PDAC has advised that Lykos has not collected enough safety data on the molecule in its trials so far.

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

Despite this setback in the US, countries such as Canada and Australia have increased legal access to MDMA-assisted psychotherapy for PTSD in recent years.

However, there are concerns about the safety profile of the drug due to its side effects such as tachycardia, high blood pressure, and liver and nerve damage despite promising studies.

Safer alternatives

Now, published in the Journal of Neurochemistry, an international research team led by Harald Sitte at MedUni Vienna’s Center for Physiology and Pharmacology has identified three new variants of MDMA as promising alternatives for safer use.

According to the team, the variants – ODMA, TDMA and SeDMA – have been developed to retain the positive effects of MDMA while reducing negative effects.

The studies suggest that the variants impact structures in the brain such as serotonin and dopamine in a similar way to MDMA, but unlike MDMA, they have lower activity at certain serotonin receptors.

Study lead Harald Sitte stated: “This allows the conclusion that both the acute and long-term side effects of ODMA, TDMA and SeDMA may be lower than those of the conventional substance.”

“Since the MDMA analogues also have a weaker interaction with certain transport proteins in the body that are responsible for the absorption and excretion of drugs, the risk of interactions with other drugs could also be reduced,” added first author, Ana Sofia Alberto-Silva.

Sitte continued: “Our experimental results showed that the new variants can retain the therapeutic potential of the conventional substance, but are likely to cause fewer side effects.

“This could advance the controlled use of psychoactive substances in neuropsychiatric illness.”

The authors wrote: “Our findings suggest that these new MDMA bioisosteres might constitute appealing therapeutic alternatives to MDMA, sparing the primary pharmacological activity at hSERT, hDAT, and hNET, but displaying a reduced activity at 5-HT2A/2B/2C receptors and alternative hepatic metabolism. Whether these MDMA bioisosteres may pose lower risk alternatives to the clinically re-emerging MDMA warrants further studies.”

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



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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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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