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Delivery system enables administration of psychedelics without side effects

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Delivery system enables administration of psychedelics without side effects

Psycheceutical has been granted exclusive license of two major patents that will psychedelic compounds to be administered without any side effects.

Psycheceutical‘s patented delivery systems will enable psychedelics such as psilocybin, ibogaine and ketamine to be administered without side effects and toxicity by bypassing the stomach and the liver.

The delivery systems will enable the administration of psychedelic compounds without passing through the digestive tract, which will improve uptake and minimise harmful side effects, and will also eliminate the hallucinogenic effect of the compounds.

The delivery systems  

The first system, the Janus particle solution, which was established following groundbreaking research conducted at the University of Michigan by Professor Dr Anish Tuteja, uses layered nanoparticles that target specific cells and deliver multiple medicines at different times and rates.

Dr Tuteja, who has now joined Psycheceutical as chief science officer, commented: “The Janus particle technology has immense potential to transform the delivery of psychedelic therapies amid today’s mental health crisis. Nearly all forms of research being done on psychedelics are via the digestive tract, which slows uptake, requires higher dosage, and may lead to harmful side effects in the body.

“By leveraging nanoparticle encapsulation, Psycheceutical will overcome these limitations. Psycheceutical aims to provide similar nanoparticle-based solutions to any and all companies doing psychedelic drug development research.”

The second system, NeuroDirect™, enables the direct administration of neuroactive compounds to nerve connections to the brain, bypassing the blood-brain-barrier. 

This enables smaller doses, improved efficacy of the active compound, and immediate response, as well as eliminating potentially toxic effects. This delivery method also removes the hallucinogenic effects of the compounds. 

See also  atai announces results of ibogaine trial for opioid use disorder

Removing the psychedelic experience

Psycheceutical says the delivery systems’ ability to eliminate the hallucinogenic effects of psychedelic medicines will facilitate wider medical adoption and use.

NeuroDirect™ technology developer, Dr Aung Din, said: “Having practiced neurology and neuropsychiatry for 30 years and been involved in clinical research to bring numerous drugs through the FDA to market, I am particularly excited about Psycheceutical’s work to deliver potentially harmful psychedelics in a safe way for medical purposes. 

“The ability to avoid the systemic side effects of psychedelic compounds, such as nausea, dizziness, and disorientation, opens up a whole new world to neuro-therapeutics.”

“Combining the patented technologies of the Janus particle solution with the NeuroDirect™ delivery system solves the problem most psychedelic drug development companies are targeting: a safe, effective, take-at-home drug. The stronger the medicine, the more likely the need for on-site medical oversight; this layers in massive costs. NeuroDirect delivery, by eliminating toxicity and hallucinogenic properties, solves that problem,” said Chad Harman, CEO of Psycheceutical.

“The Janus particle solution will allow for time-released and combined therapies to be administered to patients, targeting specific indications. These breakthrough technologies that allow psychedelic compounds to be delivered in a safer and more effective way are a revolution for the entire psychedelic industry.”

Zappy Zapolin, Psycheceutical chief visionary officer, said: “My unique experience, access, and understanding of the psychedelic industry gives our company, Psycheceutical, a strategic advantage in targeting and acquiring valuable intellectual property and talent flying under the radar of other players in the space.

“Looking at the industry as it is growing, we are seeing the emergence of a brand-new sector: the psycheceutical industry, which merges the best of psychedelics and the best of pharmaceuticals. Psycheceutical is on a mission to bring safety and efficacy to psychedelic compounds with patented delivery systems designed specifically for this new class of medications.”

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Markets & Industry

Major deals continue positive trajectory for psychedelics in 2024

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“Enhanced Consciousness Index” tracked by new psychedelics ETF

Psychedelics started 2024 with a bang, and the innovative medicines are continuing to gain traction as the year progresses. This week saw one of the globe’s top five biggest pharmaceutical companies – AbbVie – enter the market, while Enveric and MindBio signed a $66.5 million deal.

2024 set off to a strong start for psychedelic medicines with several watershed moments that are setting the stage for the sector’s acceleration.

These include developments such as the FDA’s acceptance of Lykos Therapeutics’ NDA for MDMA-assisted therapy for PTSD, Beckley Psytech’s securement of $50M investment from atai Life Sciences to expedite its assets through Phase 2 trials, a European Medicines Agency meeting on regulating psychedelics, and the confirmation from the UK’s independent policy body POST that it will publish a major briefing on psychedelic drugs to treat mental health conditions later this year, among others.

The positive developments for the industry are continuing, with this week seeing pharmaceutical company AbbVie – which has a clinical pipeline covering neuroscience, immunology, oncology, and eyecare – entering the industry through a new $65 million partnership with psychedelic drug developer Gilgamesh Pharmaceuticals.

Next generation neuroplastogens

The companies have stated they will be working together to discover and deliver next-generation psychedelics for mental health conditions such as anxiety, depression, and PTSD, as well as addiction.

AbbVie has highlighted the challenges posed by first-gen psychedelics including necessitating in-office administration and concomitant supportive care due to their hallucinogenic component – elements that could hinder the adoption and scale-up of these medicines.

See also  MDMA for PTSD receives priority review for New Drug Application

Gilgamesh Pharmaceuticals is working on the development of next-gen compounds that aim to improve the safety and efficacy of first-generation psychedelics and remove the hallucinogenic component, including a short-acting 5-HT2A agonist and an Ibogaine analogue.

In a press statement, Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research at AbbVie, commented: “Significant unmet need remains for people living with psychiatric disorders and we know that to innovate in this field, we need to pursue novel technologies and approaches.

See also  UK advisory body issues rapid response on psychedelics for PTSD

“We look forward to working with Gilgamesh’s world-class team to advance the development of novel neuroplastogens and pave the way for additional treatment approaches in psychiatry.”

Jonathan Sporn, M.D., chief executive officer at Gilgamesh Pharmaceuticals, added: “We are thrilled to partner with AbbVie, a global pharmaceutical company focused on innovation in psychiatric care, to address the pressing challenges in mental health treatment.

“Our collaboration will pioneer research of a new generation of therapies that hold great potential for improving patient outcomes.”

AbbVie is now the latest major pharmaceutical company to enter this market, following the likes of Janssen and Janssen and Otsuka Pharmaceutical, indicating that mainstream pharma is taking the promise of psychedelic medicines seriously.

However, this was not the only major deal to take place in the psychedelics market this week.

Enveric Biosciences also signed a $66.5 million non-binding term sheet with MindBio Therapeutics to out-license its novel psilocin prodrug candidate for mental health disorders.

Similar to Gilgamesh Pharmaceuticals, Enveric and MindBio focus on the development of next-generation neuroplastogens for that have reduced the hallucinogenic component.

Under the non-binding term sheet, Enveric will out-license a class of Novel Psilocin Prodrugs (NPP) to MindBio – a group of molecules that the company says are designed to be metabolised specifically to release therapeutic levels of systemic psilocin at varying rates.

In a press statement, Joseph Tucker, Ph.D., Director and CEO of Enveric, commented: “We look forward to working with MindBio’s team, which is pioneering an important part of the exciting psychedelic space, focused on controlling dose to reduce or eliminate hallucinations associated with these powerful compounds.

“This non-binding term sheet highlights the potential synergies between the Enveric and MindBio approaches to leveraging psychedelic-based compounds to target specific signaling pathways in the brain for the treatment of neuropsychiatric conditions.”

“We are pleased to explore an opportunity to draw on the molecular discovery engine at Enveric and believe this novel and patented asset significantly strengthens our intellectual property pipeline and aligns with our strategy to develop innovative, protected compounds with fine-tuned formulation and dosing strategies,” added CEO of MindBio, Justin Hanka.

“We look forward to the prospect of progressing this asset into clinical trials as we seek to bring important and beneficial therapies to patients in need.”

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Policy

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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Research

Is connection key? How clinicians impact patient outcomes in psychedelic therapy

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A wealth of research is showing how psychedelic-assisted therapy holds promise for the treatment of mental health conditions such as depression, but what role does the therapist play in a patient’s outcome? A new study has suggested it may be a big one.

Psychedelics have piqued huge interest due to their effects on the brain. Research points to their ability to induce neuroplasticity in the brain as one of the key reasons they may help with conditions such as depression and anxiety.

However, set – the individual’s (or patient’s) mental state – and setting – the individual’s environment during a psychedelic experience – are hugely impactful on the outcome of these experiences.

In the traditional use of psychedelic medicines, shamans help to guide set and setting throughout the experience with singing, drumming and ritual. Today, in scientific research, trials, and in clinics, the clinician is essentially playing this role.

Senior author of a new study, Alan Davis, associate professor and director of the Center for Psychedelic Drug Research and Education in The Ohio State University College of Social Work, has highlighted that the impact of clinicians on patient outcomes is not new, with research consistently showing that a trusting relationship between patients and clinicians has been key to better outcomes. This concept is known as a “therapeutic alliance”.

Understanding the therapeutic alliance

To find out more about the impact of this therapeutic alliance in psychedelic therapy, researchers from Ohio State University College of Medicine analysed data from a clinical trial that investigated psilocybin-assisted psychotherapy for the treatment of major depressive disorder (MDD).

In the trial, participants received two doses of psilocybin and 11 hours of psychotherapy, completing a therapeutic alliance questionnaire afterward, which assessed the strength of the therapist-participant relationship.

Participants also completed questionnaires about any mystical and psychologically insightful experiences they had during the drug treatment sessions. In psychedelic research, the mystical experience has often been shown to be related to the continuing positive effects of this therapy.

The Ohio team looked at the depression outcomes alongside patient reports about their experiences with the medicines as well as their connection with their therapists.

They found that a stronger relationship between patient and clinician led to a better clinical outcome for the patient – with improved depression scores up to 12 months following the experience.

Lead author Adam Levin, a psychiatry and behavioral health resident at Ohio State University College of Medicine, stated: “What persisted the most was the connection between the therapeutic alliance and long-term outcomes, which indicates the importance of a strong relationship.”

Analysis results revealed that over time, the alliance score increased, and in fact demonstrated more acute mystical experiences for the patient. The team also found that acute effects were linked to lower depression four weeks following treatment, but were not associated with better depression outcomes a year after the trial.

“The mystical experience, which is something that is most often reported as related to outcome, was not related to the depression scores at 12 months,” Davis stated.

“We’re not saying this means acute effects aren’t important – psychological insight was still predictive of improvement in the long term. But this does start to situate the importance and meaning of the therapeutic alliance alongside these more well-established effects that people talk about.”

According to the team, the analysis showed that a stronger relationship during the final therapy preparation session predicted a more mystical and psychologically insightful experience – which in turn was linked to further strengthening the therapeutic alliance.

“That’s why I think the relationship has been shown to be impactful in this analysis – because, really, the whole intervention is designed for us to establish the trust and rapport that’s needed for someone to go into an alternative consciousness safely,” Davis stated.

“This isn’t a case where we should try to fit psychedelics into the existing psychiatric paradigm – I think the paradigm should expand to include what we’re learning from psychedelics,” Levin added.

“Our concern is that any effort to minimise therapeutic support could lead to safety concerns or adverse events. And what we showed in this study is evidence for the importance of the alliance in not just preventing those types of events, but also in optimizing therapeutic outcomes.”

The authors emphasised that efforts to minimise negative experiences in future studies of psychedelics is vital, and that therapy is critical to creating a supportive environment for patients.

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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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