USA: BIDEN Administration plans for legal legal psychedelic therapies within two years

 

A letter from the Health and Human Services Department discloses the anticipated FDA approval of MDMA and psilocybin treatments.

As twwin mental health and drug misuse crises kill thousands of people per week, the potential of psychedelic-assisted therapies “must be explored,” urges a federal letter on behalf of the U.S. health secretary and shared with The Intercept. 

 

President Joe Biden’s administration “anticipates” that regulators will approve MDMA and psilocybin within the next two years for designated breakthrough therapies for PTSD and depression, respectively. The administration is “exploring the prospect of establishing a federal task force to monitor” the emerging psychedelic treatment ecosystem, according to the letter sent by Assistant Secretary for Mental Health and Substance Use Miriam Delphin-Rittmon to Rep. Madeleine Dean, D-Pa.

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The High-Stakes Race to Engineer New Psychedelic Drugs

The May correspondence, not shared publicly until now, is the clearest indication yet that top officials are preparing for the approval of psychedelic drugs — demonized for decades after former President Richard Nixon sought means to attack the anti-Vietnam War counterculture in the late 1960s — which was arguably unthinkable even five years ago.

But as evidence grows of the healing potential of certain controlled substances, including many hallucinogens, the war on drugs in the U.S. is steadily being wound down. Late Friday, the Drug Enforcement Agency dropped plans to schedule several DMT analogues after facing serious opposition, including a legal threat from companies Mindstate, Tactogen, and Panacea Plant Sciences.

The move followed Thursday’s introduction of a bipartisan bill, co-sponsored by Sens. Cory Booker, D-N.J., and Rand Paul, R-Ky., to force the DEA to stop barring terminally ill patients from trying controlled drugs which have passed early trials. The right to try experimental therapies has been enshrined in federal law since 2018, but the DEA currently blocks its use among people with late-stage cancer who wish to be treated with psilocybin, a Schedule I controlled substance.

“Studies have shown that psilocybin produces substantial and sustained decreases in depression and anxiety among patients with life-threatening cancer,” Booker wrote in a statement tweeted Thursday. “While typically terminally ill patients are allowed to access drugs that are in FDA clinical trials, they are barred from accessing Schedule I drugs, despite their therapeutic potential.”

In the letter obtained by The Intercept, Delphin-Rittmon said that the Substance Abuse and Mental Health Services Administration, or SAMHSA, responding to Dean on behalf of Health and Human Services Secretary Xavier Becerra, “agrees that too many Americans are suffering from mental health and substance use issues, which have been exacerbated by the ongoing COVID-19 pandemic, and that we must explore the potential of psychedelic-assisted therapies to address this crisis.”

Dean had proposed an interagency task force, the letter notes, to lead a public-private partnership and address “the myriad of complex issues associated with the anticipated approval by the [FDA] of [MDMA] for the treatment of post-traumatic stress disorder and psilocybin for the treatment of depression within approximately 24 months.”

According to Delphin-Rittmon, SAMHSA and the assistant secretary for health are considering the establishment of such a task force including the private sector. “Collaboration across federal agencies with outside stakeholders will be the most effective way to ensure we are thoughtfully coordinating work on emerging substances such as MDMA and psilocybin,” she wrote. 

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The Psychedelics as Medicine Report (I)

The use of psychedelics as medicine has opened up a new industry growing exponentially at a rapid pace. 

_PSYCH tracks key psychedelic players, innovations and milestones, providing trustworthy insights to help investors cut through the noise and identify real opportunities. 

_PSYCH provides a coercive perspective on the commercial impact of changing global regulations, drug discovery and corporate activity. We connect operators to a qualified audience with access to capital, ready to support industry growth and help them achieve their goals. 

_PSYCH unlocks the commercial potential of psychedelics.

The psychedelic substances profiled in this report are either naturally occurring, such as psilocybin, ayahuasca and ibogaine; or, like LSD and MDMA, are (semi-)synthetically manufactured in a laboratory setting. Naturally occurring psychedelics, such as psilocybin, can also be synthetically manufactured. 

Novel psychedelic compounds can also be synthesised based on existing substances.

 If the United States FDA awards a substance/ treatment Breakthrough Therapy designation (BTD), this means the FDA will expedite the substance’s development and review process because clinical evidence has shown that it may offer a substantial improvement over existing therapies. BTD has been given to COMPASS Pathways and Usona Institute to develop psilocybin to treat depression, to the Multidisciplinary Association for Psychedelic Studies (MAPS) which is developing MDMA to treat post-traumatic stress disorder (PTSD), and to Janssen & Janssen for the treatment of TRD with Spravato.

•  Serotonin (5-HT)
•  Indole alkaloid
•  Psychedelics
•  Psilocybin (‘magic’ mushrooms)
•  Ibogaine
•  Mescaline (peyote)
•  Ayahuasca
•  DMT
•  5-MeO-DMT
•  LSD
•  MDMA
•  Ketamine
•  Esketamine
• Salvia divinorum  
  
  
   
  

Ahora Pharma también es "WOKE": WOKE Pharmaceuticals

 

Woke Pharmaceuticals Pty Ltd is an Australian-based company focused on the development and commercialisation of novel psychedelic therapies for the treatment of mental health disorders

About 20% of Australians struggle with a mental illness every year, ranging from depression and anxiety to substance or alcohol abuse. The potential hardship and isolation posed by COVID-19 risks leaving more people vulnerable.

While there is a range of pharmaceutical and psychological treatments for mental illness, these may not be effective in some people, or at least they may still leave people with residual symptoms. Additionally, there are usually side effects which commonly occur from these drug therapies.

Given the scale of mental illness in society, innovative new treatment approaches are urgently needed. One of these new approaches is the medicinal use of previously prohibited psychedelic compounds such as magic mushrooms. There have been several successful clinical studies across the world that have shown the potential benefit of psychedelics for treatment of psychiatric disorders. 

Ver:

Todo sobre  psilocybin en PHARMACOSERÍAS

Woke Pharmaceuticals' lead candidates are based on synthetic psilocybin for the treatment of depression. Psilocybin is a naturally occurring psychedelic prodrug compound produced by more than 200 species of fungi. The safety and efficacy of psilocybin has been demonstrated in multiple studies.

Mission Statement 

Woke Pharmaceuticals is dedicated to developing novel psychedelic therapies as registered medical treatments for mental health disorders and other neurological diseases, as well as supporting psychological wellbeing. We aim to achieve this through the development of novel formulations, rigorous research and clinical trials, and partnerships with world-class researchers, institutions, organisations, and corporations.

 

Para el 2021, "woke" se había usado casi exclusivamente como un concepto peyorativo, y los usos más destacados de la palabra tienen lugar en un contexto despectivo.​ Aunque en español no tiene una traducción asentada y generalmente se usa el término inglés crudo, destacada en cursiva o entrecomillada al ser un extranjerismo, en la jerga coloquial de España se llama despiertismo a este movimiento y despiertos o despiertitos a los que lo siguen, el primero como término neutro y el segundo despectivo. Una traducción propuesta por la RAE es concienciado.

FDA "resucita" LSD con fines terapéuticos

Several decades after Timothy Leary began evangelizing the benefits of LSD, the Food and Drug Administration is looking into the drug’s benefits.

The FDA has cleared a phase 2b study of an anxiety treatment that uses a pharmacologically optimized form of LSD. Mind Medicine (also known as MindMed), the biopharmaceutical company that developed the drug, says it expects clinical trials to start “in early 2022.”

Ver:

Todo sobre LSD en PHARMACOSERIAS

 

“This trial, the first commercial study of LSD in more than 40 years, builds on productive discussions with FDA and provides an opportunity to explore improvements in anxiety symptoms,” said MindMed CEO and director Robert Barrow in a statement.

The experimental drug, called MM-120, focuses on generalized anxiety disorders and other brain-based disorders. Phase 2b trials are designed to test the efficacy of a drug, looking at its success rate in treating a disorder or disease.

In the case of MM-120, MindMed says it will begin a dose-optimization trial with 200 patients, which will guide dose selections in Phase 3 trials (which generally involve a larger number of patients and look at how a medicine works compared to existing treatments). Researchers hope to determine how much the LSD-based drug reduces anxiety symptoms over 12 weeks after a single dose.

LSD isn’t the only psychedelic drug MindMed is looking to bring to clinical use. Its pipeline also includes products that use psilocybin (aka “magic mushrooms”), MDMA (Molly or Ecstacy) and DMT, a hallucinogenic drug that occurs naturally in many plants and animals.

“With a clear regulatory path, we look forward to building on this momentum and advancing this trial as quickly and efficiently as possible,” said Barrow, “bringing us significantly closer to transforming the treatment landscape for patients who suffer from anxiety.”

FDA clears LSD-based anxiety drug for clinical trials 

By CHRIS MORRIS January 26, 2022

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The Psychedelics as Medicine Report (IV)

 

Ver:

The Psychedelics as Medicine Report (III)

Psychedelics have taken a torturous path through medicine; resolving early issues of set and setting, mimicry versus cause of psychosis, arguments about toxicity and regulatory challenges. The socio-political climate changed significantly in the late 1980s. And now, in the twenty first century, psychedelic research is well established again. But this time the medical profession’s slant is different. There is less novelty about cultural psychedelia and less emphasis on changing the world. Today, the general public understand drugs far better than in the 1960s. They recognise that it is methamphetamine, crack and alcohol that cause dependence and destruction, whe- reas that drugs like LSD, psilocybin, cannabis and MDMA can be used safely. They are simply too pharmacology savvy to fall for the blanket and unsophisticated “Just Say No.” Together with tremendous advances in neuroimaging, providing visualisation not only of the anatomical structure of the brain but also its direct physiological changes in real time, psychedelics have become the ideal tools for a bespoke approach to neuroscience. In the dying embers of the War On Drugs, the therapeutic validity of psychedelics is impossible to ignore.

Global institutions are working in harmony towards a shared goal. But there remain challenges. There is little support from the pharmaceutical industry; perhaps unsurprising given that psychedelic treatments use drugs that are out of patent. Plus, psychedelic therapy is the antithesis of the traditional maintenance therapies we use in modern psychiatry. Through focusing on objective scientific data neuroscientific studies raise the profile of contemporary research and pull in greater mainstream acceptance for the field. Meanwhile, cross-cultural studies are teaching us about the holistic management of mental disorders. 

The concepts of Mindfulness and Wholeness are now commonplace in psychiatry; broadening our minds as to what we consider “psychedelic.”

Psychiatry today is where nineteenth century general medicine was before the discovery of antibiotics; expert at the identification and classification of common disorders but lacking globally agreed treatments. It could be that psychedelic therapies, however, can offer psychiatry the best opportunity to effectively tackle trauma using guided psychotherapeutic techniques; driven by a holistic, naturalistic and personalised care approach that is currently lacking. Psychedelic psychiatry is in desperate need of good PR if it is to realistically meet modern demands and become clinically deliverable for large populations. This is our challenge for the future. Given the pace of recent clinical research, we are clearly in the midst of a psychedelic renaissance and the best is yet to come. Watch this space

The History of Psychedelics in Medicine / Ben Sessa 

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