TuesdayAug 27, 2024 10:00 am

MDMA Rejection Raises New Questions on Psychedelic Drug Clinical Trials

The U.S. Food and Drug Administration (FDA) recently rejected an application to approve the use of MDMA as a treatment for post-traumatic stress disorder (PTSD). The MDMA formulation, developed by Lykos Therapeutics, would have been administered in combination with psychotherapy if it had been approved. In its rejection, the federal agency requested for more clinical trials to be done to gather additional data on the drug’s effectiveness and safety. This decision comes just months after the FDA’s advisory committee determined that the application made by Lykos was lacking on both fronts. The decision is a significant change in the drug’s…

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ThursdayAug 22, 2024 10:00 am

Study Suggests Psilocybin Triggers Mechanisms for Inner Healing within Depression Patients

Psychedelics are known to alter an individual’s mood, perception and cognitive processes when ingested. These substances can also alter one’s perception of time, induce hallucinations, and lead to deep introspective and emotional experiences. Individuals who use psychedelics have reported that the drugs may facilitate inner healing through promoting introspection and emotional release. The drugs can also help alleviate feelings of depression and isolation by creating a feeling of unity and interconnectedness. Now new research has looked into whether psilocybin can prompt inner healing for patients with depression. The research is based on a hypothesis that people who consume a high…

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TuesdayAug 20, 2024 2:15 pm

FDA’s Rejection of MDMA Therapy Draws Ire of Psychedelics Experts

Last week, the U.S. Food and Drug Administration (FDA) rejected a new drug application for MDMA to be administered as treatment for post-traumatic stress disorder. In its rejection, the federal agency asked the company that filed the application, Lykos Therapeutics, to conduct additional trials to further study the effectiveness and safety of its psychedelic formulation. This would require additional funding as well as a number of years to complete, which doesn’t align with Lykos Therapeutics’ expectations. The FDA’s ruling left many upset, particularly experts and patient advocates involved in the development and research of psychedelic treatments. One neuroscientist at the…

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ThursdayAug 15, 2024 10:00 am

FDA Rejects MDMA Therapy Application, Calls for More Research

Last week, the U.S. Food and Drug Administration (FDA) made the decision not to approve MDMA-assisted therapy for post-traumatic stress disorder. This decision comes just months after advisors to the agency voted against evidence supporting MDMA therapy. The agency’s decision was based mainly on concerns about issues with clinical research. The advisors’ decision to not approve the treatment put the agency in a bind, given that historically, it sides with this committee. The recent news was a huge blow to Lykos Therapeutics and the broader movement focused on bringing psychedelics into mainstream mental-health care. Instead, the FDA directed that the…

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TuesdayAug 13, 2024 10:00 am

UC Davis Researchers Unveil Tool for Quickly Showing Psychedelics’ Neuronal Impact

Interest in the effectiveness of psychedelic drugs as treatments for disorders such as substance use disorder, PTSD and depression has grown in the last few years. Thus far, different studies have determined that psychedelic compounds, such as psilocybin, DMT and LSD, promote the strengthening and growth of neurons and their connections in the prefrontal cortex. This region in the brain plays a role in executive function, including reasoning and decision making. Now, scientists at UC Davis have invented a tool that can track how psychedelic substances activate biomolecules and neurons in the brain. The rapid noninvasive tool, dubbed Ca2+-activated Split-TurboID…

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FridayAug 09, 2024 10:00 am

Massachusetts Lawmakers Forward Bill Creating Psychedelics Working Group to Governor’s Desk

Legislators in the state of Massachusetts have forwarded a measure focused on military veterans to the governor’s desk for approval. The measure includes provisions to establish a psychedelic working group to conduct research and give recommendations on the potential therapeutic benefits of psychedelics like MDMA and psilocybin. In particular, the group would explore whether psychedelic therapy was linked to improved outcomes among veterans diagnosed with a range of mental-health conditions while also looking for alternative mental-health treatments for veterans. The measure, titled the HERO Act, was initially introduced by Governor Maura Healey in November 2023. It should be noted that…

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TuesdayAug 06, 2024 10:00 am

Company Receives First Psilocybin Edible Manufacturing License from Oregon Authorities

Oregon regulators have issued the state’s first-ever psychedelic edibles manufacturer license to Spiritus Oregon, a Milwaukie-based company that manufactures psilocybin edibles. The company offers its edibles under the Horizon Edibles brand, noting in a press release that its dark chocolate edibles were dosed with homogenized, dried mushrooms. This, they stated, had a nutty, earthy flavor. According to its site, Spiritus provides white-label products and manufactures its own psilocybin edibles. It is also licensed as a commercial kitchen. Horizon Edibles president, Michael Briggs, stated that the company’s products were meant to be eaten. He added that their focus had been to…

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ThursdayAug 01, 2024 10:00 am

Study Says Psilocybin Helps Alcoholics by Genetically Changing Brain’s Reward Center

Alcohol use disorder is a disorder characterized by an inability to stop or control one’s drinking despite adverse health, occupational or social consequences. Conventional treatments include medication, behavioral therapy, and support groups. Even with these treatments, however, many individuals find it hard to achieve lasting recovery, highlighting the need for more effective therapies. Now, a new study has determined that psilocybin decreases the consumption of alcohol in rats by modifying certain pathways in the brain. Psilocybin is a psychedelic compound that occurs naturally in some species of hallucinogenic mushrooms. For centuries now, it has been used in different spiritual and…

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TuesdayJul 30, 2024 10:00 am

New Report Discusses Policy Options on Psychedelic Sales, Use

Psychedelic policies at the state level have been evolving as more states decriminalize these substances. This has highlighted the need for conversation on how psychedelic sales would operate in a way that retains safety measures and essential regulation while still broadening access to their therapeutic benefits. RAND Drug Policy Research Center recently released a report discussing potential policy options for psychedelic sales. The think tank’s report begins by emphasizing that the time has come for federal policymakers to decide how psychedelics would be supplied, especially since legislation for retail psychedelics are already being discussed in some states. It highlights that…

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ThursdayJul 25, 2024 10:00 am

New Studies Uncover Fascinating Findings on Psilocybin

Over the last couple of years, interest in psychedelics and their therapeutic potential has risen significantly. Psychedelics such as psilocybin have shown to be useful in treating a variety of conditions, including anxiety, addiction and depression. Psilocybin is the primary psychoactive compound found in some species of hallucinogenic mushrooms. When administered, this compound synthesizes into psilocin and interacts with an individual’s serotonin receptors, altering their state of consciousness and giving way to changes in their mood as well as their perception of things. Researchers have uncovered a lot about how psilocybin affects an individual’s behavior and brain. Below, we look…

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