Psychedelics

MGC Pharma granted approval in Slovenia to manufacture and conduct research into psychedelics

Published

1 year ago

April 6, 2023

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Stockhead..

The approval in Slovenia will allow MGC Pharma to become one of the first movers in the burgeoning space of psychedelics.

MGC Pharma (ASX:MXC) is set to expand its European footprints further after receiving permission from the Slovenian Ministry of Health to undergo scientific research on the psychedelic compound, psilocybin.

The permission allows MGC to develop analytical methods, research physical-chemical properties of psilocybin, and undergo the development of pharmaceutical forms that would be suitable for administration in Slovenia.

It will also enable MGC to provide services related to the growing industry of psychedelics.

“We are pleased to have obtained permission from the Slovenian Ministry of Health to undertake pharmaceutical research with psilocybin, which puts the company at the forefront of experimental, pharmaceutical research,” said MGC Pharma CEO, Roby Zomer.

“We are extremely grateful to the Slovenian Health Ministry for enabling us to utilise our research expertise in this area.”

An early mover

MGC Pharma is one of the first companies in the world and the first in Slovenia to obtain permission to undertake pharmaceutical research on psilocybin.

Psilocybin is a naturally occurring psychedelic compound found in a variety of fungi and mushrooms, which shows great potential in many serious medical conditions.

Research into the medical use of psilocybin has recently gained attention at a global level.

In Australia, the TGA announced in February that it will be granting permission for the prescribing of psilocybin for the treatment-resistant depression, and MDMA for the treatment of post-traumatic stress disorder (PTSD), commencing on the 1st July.

Following the approval in Slovenia today, MGC can now provide development anid compounding services to companies dealing with psilocybin who wish to have a medicine in the market. This means MGC can research, develop and manufacture for third parties, which has the potential to open up new business unit and future revenue stream for the company.

As a next step, the company says it plans to work with other pharmaceutical businesses to collaborate and provide research capabilities for understanding of the properties of psilocybin.

“Whilst we continue to focus on our core development pipeline of CimetrA and CannEpil, we look forward to working with other pharmaceutical partners to establish the properties of psilocybin and demonstrate how it could be used to develop medicines to treat people with debilitating conditions,” said Zomer.

MGC Pharma has a rapidly expanding pipeline.

In March, the company announced the inclusion of lead asset ArtemiC into the US FDA’s NDC database, which means that the clinically tested COVID-19 treatment could now be sold through the US Pharmacy Benefit Management (PBM) networks starting this month.

This article was developed in collaboration with MGC Pharma, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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Psychedelics

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

Published

2 days 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

2 weeks 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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antidepressants

Treating Depression: Psychedelics vs. Antidepressants

Published

2 weeks ago

May 9, 2024

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Recent research suggests that psychedelics and traditional antidepressants, while both potentially effective in treating depression, work through distinct mechanisms. Understanding these differences could lead to more personalized and effective treatment approaches. Psychedelics vs. Antidepressants: What are the key differences?

Unlocking the Mysteries of Depression Treatment: Psychedelics vs. Antidepressants

The quest for effective depression treatments continues to be a significant focus in mental health research. Traditional antidepressants, like selective serotonin reuptake inhibitors (SSRIs), have been a mainstay in treatment, prescribed widely despite varying efficacy among individuals and often accompanying unwanted side effects. In contrast, psychedelics have recently garnered attention for their rapid and enduring antidepressant effects observed in clinical trials.

A recent study has delved into the distinct mechanisms of action of SSRIs and psychedelics, illuminating how they uniquely influence the brain and potentially alleviate symptoms of depression. SSRIs primarily increase serotonin levels in the brain, which is believed to enhance mood and diminish depressive symptoms. However, this process can require several weeks to manifest noticeable effects, and not all patients respond favorably to SSRIs.

Conversely, psychedelics such as psilocybin, found in “magic mushrooms,” operate through a different mechanism. Research indicates that psilocybin’s antidepressant effects are not directly due to elevated serotonin levels. Instead, psilocybin is thought to promote neuroplasticity, the brain’s capacity to reorganize and form new neuronal connections. This heightened neuroplasticity may facilitate more adaptable thought patterns and an improved ability to process emotions, contributing to the rapid and sustained antidepressant effects seen in clinical trials.

Moreover, the study examined the role of the 5-HT2A serotonin receptor, a primary target for both SSRIs and psychedelics. While SSRIs inhibit this receptor’s activity, psychedelics activate it. Intriguingly, blocking the 5-HT2A receptor did not reduce psilocybin’s antidepressant effects, suggesting that its therapeutic benefits originate from other pathways.

Psychedelics vs. Antidepressants: Why It Matters?

Understanding the distinct mechanisms by which psychedelics and antidepressants affect the brain is crucial for the development of more personalized and effective treatment strategies for depression. This knowledge could lead to enhanced patient selection for specific treatments, reducing trial and error while optimizing outcomes. Furthermore, exploring the unique properties of psychedelics may pave the way for novel antidepressant medications that are quicker acting and have fewer side effects.

Potential Implications

This research could catalyze a shift in depression treatment paradigms, moving from a one-size-fits-all approach to more targeted therapies. By pinpointing the specific mechanisms that underlie different antidepressant interventions, clinicians can customize treatment plans based on individual patient profiles and needs. This personalized approach could improve treatment success rates and enhance the quality of life for individuals battling depression.

What Next?

While the study of psychedelics for therapeutic purposes is still in its nascent stages, the initial findings are promising and suggest that psychedelics may offer a valuable addition to the arsenal of tools for combating depression and other mental health conditions.

Source: Neuroscience News

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