Psychedelics

Article The Lancet: The therapeutic potential of psychedelics: the European regulatory perspective

Published

1 year ago

February 21, 2023

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In the EU, mental health problems affect more than one in six people with considerable impacts for individuals and society and economic costs that exceed 4% of gross domestic product across the EU.

There is a need for effective, safe new treatments for mental disorders. In the past decade there has been a renewed interest worldwide in psychedelics as potential treatments for various mental health conditions,such as treatment-resistant depression, addictive disorders, post-traumatic stress disorder, and end-of-life psychological distress.

These psychoactive compounds have overlapping effects via different mechanisms of actions which, in the context of therapeutic use, remain to be established.Psychedelic substances induce alterations of consciousness, including visual effects, transient feelings of oneness with the universe, transcendence of time and space, and ego dissolution, but can also induce anxiety and psychological distress, which can be alleviated through interpersonal support during administration.

Classic psychedelics act via 5-HT2A receptor agonism and include mescaline, N,N-dimethyltryptamine, lysergic acid diethylamide, and psilocybin. Atypical psychedelics (eg, 3,4-methylenedioxymethamphetamine and ketamine), have different pharmacological mechanisms of action and also differ in terms of legal status (eg, ketamine and esketamine are approved as medicines in the EU). We do not, therefore, include atypical psychedelics in this discussion of the European regulatory context for potential therapeutic uses of psychedelics in mental disorders. The issues we raise here are informed by our work for the European Medicines Agency (EMA), the EMA’s Central Nervous System Working Party, and the European College of Neuropsychopharmacology (ECNP).

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Psychedelics

Lykos In Patent Mode On MDMA

Published

3 weeks ago

July 5, 2024

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We don’t believe in taking out IP on MDMA

oh actually we do

Double Blind

In a shocking move that contradicts its previous stance on intellectual property, Lykos Therapeutics (formerly known as MAPS PBC) — the organization leading the movement to legalize MDMA–assisted therapy — has filed multiple patent applications for specific forms and formulations of MDMA. Prior to this revelation, which was first reported on by Psychedelic Alpha, Lykos had long been praised in the psychedelic community and media for its “altruistic stance” in not seeking patent protections as part of its strategy, instead choosing to publish its research findings in scientific literature.

MAPS’s anti-patent stance, which intended to prevent MDMA from being monopolized, stood in stark contrast to the aggressive patent strategies of competitors like Compass Pathways and Atai Life Sciences. Rick Doblins, the founder of MAPS, had been analyzing the non-patentable status of MDMA since the late ‘80s, and in an article titled “MDMA Patentability and Orphan Drug Designation,” published in 1992, he wrote:

“It could be a major setback if MAPS funded MDMA research and secured approval for its medical use only to have someone else control it through an inexpensively obtained use patent.”

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Lykos Therapeutics Quietly Moves to Patent MDMA

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Psychedelics

Press Release: PsychedelicNewsWire Named Official Media Sponsor of the 4th Annual Psychedelic Therapeutics and Drug Development Conference

Published

2 months ago

May 18, 2024

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LOS ANGELES, May 17, 2024 (GLOBE NEWSWIRE) — PsychedelicNewsWire (“PNW”), a specialized communications platform for the psychedelics sector and one of the 60+ brands powered by IBN (“InvestorBrandNetwork”), is pleased to announce that it will be the Official Media Sponsor for the 4^th Annual Psychedelic Therapeutics and Drug Development Conference (“the conference”), an industry flagship event dedicated to research and development of psychedelics in the healthcare space hosted by Arrowhead SciTech Conferences & Events (“Arrowhead”). The event will be held at the iconic Revere Hotel Boston Common, 200 Stuart Street, Boston, MA 02116 on 23-24 May 2024

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individualized treatment

Risks of Psychedelics for People with Personality Disorders

Published

3 months ago

May 9, 2024

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While psychedelics have shown promise in treating certain mental health conditions, a recent study suggests they may pose risks for individuals with personality disorders. The findings underscore the importance of careful screening and personalized approaches in psychedelic-assisted therapy.

Navigating the Psychedelic Landscape: Potential Risks for Individuals with Personality Disorders

Psychedelics, including substances like psilocybin and LSD, have gained significant traction in recent years for their potential therapeutic benefits in treating mental health conditions such as depression, anxiety, and PTSD. However, a recent publication in the Journal of Psychopharmacology has raised concerns about the suitability of these substances for individuals with personality disorders.

The study surveyed individuals who had used psychedelics and who were also diagnosed with personality disorders. A considerable number of respondents reported negative and persistent psychological impacts following their psychedelic experiences. Notably, these included heightened anxiety, paranoia, mood instability, and an exacerbation of existing personality disorder symptoms.

Researchers suggest that the vulnerability of individuals with personality disorders to the adverse effects of psychedelics may stem from pre-existing challenges in emotional regulation, self-identity, and interpersonal relationships. The profound and introspective nature of psychedelic experiences can intensify these issues, potentially leading to psychological distress and symptom aggravation.

This research highlights the critical need for thorough screening and assessment in the context of psychedelic-assisted therapy. It suggests that individuals with personality disorders might require tailored therapeutic approaches and robust support systems to navigate potential risks and to secure safe and positive outcomes.

Why It Matters

The burgeoning interest in psychedelic therapy underscores the necessity to discern both the potential benefits and risks across different demographic groups. This study contributes valuable insights, particularly for clinicians and researchers, stressing the importance of personalized treatment plans and the cautious consideration of individual vulnerabilities when administering psychedelic-assisted therapy.

Potential Implications

The findings from this study emphasize the need for ethical and responsible practices within the field of psychedelic-assisted therapy. There is a pressing requirement for the development of detailed screening protocols that can identify individuals who may be more susceptible to the adverse effects of psychedelics. Furthermore, crafting specialized therapeutic strategies that cater specifically to the needs of individuals with personality disorders is essential for ensuring their safety and overall well-being during and after undergoing psychedelic experiences.

The Bigger Picture

The debate surrounding the therapeutic use of psychedelics is complex, with various factors influencing the suitability of these treatments for different individuals. While there are promising results in general populations, the nuanced needs and potential vulnerabilities of those with personality disorders require careful consideration to prevent harm and maximize therapeutic outcomes. This necessitates ongoing research, improved clinical protocols, and a commitment to patient-centered care in the burgeoning field of psychedelic medicine.

Source: Science Alert

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