First medical marijuana, now medical psilocybin (serotonergic psychedelics)?

A bill filed in the Missouri Senate would legalize the use of psilocybin for medical use, setting the stage to nullify federal prohibition of the same in practice and effect.

Sen. Holly Thompson Rehder prefiled Senate Bill 768 (SB768) on Dec. 1. The legislation would protect “any person who acquires, uses, produces, possesses, transfers, or administers psilocybin for the person’s own therapeutic use” from state or local criminal and civil penalties if they meet the following criteria:

• Is 21 years of age or older
• Suffers from a condition listed in the act
• Has enrolled or sought to be enrolled in a clinical trial to study psilocybin to treat such conditions
• Informs the Department of Health and Senior Services that they plan to acquire, use, produce, possess, transfer, or administer psilocybin under this act
• Provides the Department with specified documentation and information
• Ensures the psilocybin is tested in a licensed laboratory, and
• Limits the use of psilocybin to no more than 150 milligrams of psilocybin analyte during any 12-month period.

The legislation also protects any person “who assists another in any of the acts permitted under this act and any laboratory testing psilocybin.”

Psilocybin, often referred to as “magic mushrooms,” is a hallucinogenic compound found in certain mushrooms. Several studies have shown psilocybin to be effective in the treatment of depression, PTSD, chronic pain and addiction. ...

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Shares of clinical stage biopharmaceutical company MindMed will once again be on watch Friday after rocketing higher during Thursday's cash session by more than 51% on more than 30x the company's average volume.

The company announced on Thursday it had received breakthrough therapy designation by the FDA and announced positive 12 week durability data from a Phase 2B study of its candidate, MM120, for generalized anxiety disorder.

The news was enough to send shares, which have an all time high short interest, rocketing higher.

David Feifel, MD, PhD, Professor Emeritus of Psychiatry at the University of California, San Diego and Director of the Kadima Neuropsychiatry Institute in La Jolla, California and an investigator in the MM120 study commented: “I’ve conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable."

He continued: “These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future Phase 3 trials.”

Robert Barrow, Chief Executive Officer and Director of MindMed added: “The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD.”
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Serotonergic psychedelics such as LSD, psilocybin, and DMT increase the creation of new neurons and parts of neurons (neurogenesis and spinogenesis) and connections between neurons (synaptogenesis)[4], which facilitates increased communication between neurons. Evidence suggests that while under the influence of psychedelics, the brain shows increased connectivity, including connections between areas of the brain that aren’t normally directly connected[8]. This process may help to reverse some degree of the changes that result from negative experiences, depression, anxiety, PTSD, and substance misuse[1,7,8].
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Efforts to make MDMA legally available as a psychotherapeutic catalyst hit a daunting roadblock on Tuesday when an expert panel overwhelmingly voted to recommend that the Food and Drug Administration (FDA) reject a new drug application that Lykos Therapeutics submitted in February. Members of the panel expressed several concerns about two Phase 3 studies of MDMA's safety and effectiveness in treating post-traumatic stress disorder (PTSD), including unblinding of subjects, potential underreporting of adverse events, and allegedly inadequate assessment of MDMA's abuse potential.
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Nine of the 11 advisory committee members concluded that MDMA's effectiveness has not been demonstrated, while 10 agreed that its benefits do not outweigh its risks. "It seems like there are so many problems with the data," said panelist Melissa Decker Barone, a Department of Veterans Affairs psychologist. "Each one alone might be OK, but when you pile them on top of each other…there's just a lot of questions I would have about how effective the treatment is."
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... several concerns about two Phase 3 studies of MDMA's safety and effectiveness in treating post-traumatic stress disorder (PTSD), including unblinding of subjects, potential underreporting of adverse events, and allegedly inadequate assessment of MDMA's abuse potential. ...

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Efforts to make MDMA legally available as a psychotherapeutic catalyst hit a daunting roadblock in August. The Food and Drug Administration (FDA) declined to approve a new drug application submitted in February by Lykos Therapeutics, a company 
created by the Multidisciplinary Association for Psychedelic Studies (MAPS).

The FDA was following the recommendation of an advisory panel that had expressed several concerns about two Phase 3 studies of MDMA's safety and effectiveness in treating post-traumatic stress disorder (PTSD), including inadvertent unblinding of subjects, potential underreporting of adverse events, and allegedly inadequate assessment of MDMA's abuse potential. The FDA requested an additional Phase 3 trial, which would take years and millions of dollars. Lykos described that request as "deeply disappointing," saying it hoped existing evidence could resolve the agency's concerns.
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Goldhedge said:

What if you are addicted to psilocybin... then what?

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My Psychedelic Therapy Experiences​

U.S. veterans with PTSD take a psychedelic journey in Mexico | 60 Minutes​