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  • Australia Reclassifies Psychedelics To Facilitate Medical Use, As Advocates Push For Similar Move in US - Endpoints News

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    Australia Reclassifies Psychedelics To Facilitate Medical Use, As Advocates Push For Similar Move in US - Endpoints News

    Uploaded by

    Sunil Kumar Aggarwal

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    © All Rights Reserved
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    July 5, 2023 04:00 PM EDT

    R&D, Pharma

    Australia reclassifies psy-


    chedelics to facilitate med-
    ical use, as advocates push
    for similar move in US

    Nicole DeFeudis
    Editor

    Australia’s Therapeutic Goods Administra-


    tion (TGA) has reclassified two psychedelic
    substances to facilitate their use as medi-
    cines for certain mental health conditions,
    a move that some advocates say could
    serve as an example for the US.

    Australia announced in February that


    starting July 1, authorized psychiatrists can
    prescribe drugs containing psilocybin, an
    active substance in “magic mushrooms,”
    and MDMA for treatment-resistant depres-
    sion and post-traumatic stress disorder, re-
    spectively. Those are the only two condi-
    tions for which TGA has said there is “cur-
    rently su!cient evidence for potential ben-
    efits.”

    Psilocybin and MDMA will be reclassified


    as Schedule 8, or controlled drugs, for
    those uses and remain as Schedule 9-pro-
    hibited substances in all other circum-
    stances.

    advertisement

    advertisement

    While there are currently no TGA-ap-


    proved medicines containing psilocybin or
    MDMA, the agency said these changes will
    “allow authorised psychiatrists to access
    and legally supply a specified ‘unapproved’
    medicine containing these substances to
    patients under their care for these specific
    uses.”

    Psilocybin is currently under development


    by a variety of companies for conditions
    such as PTSD and treatment-resistant de-
    pression, while MDMA has been similarly
    studied in PTSD and anxiety in terminally
    ill patients.

    RELATED: Inside the race to make psychedelics


    'mainstream medicines'

    In the US, a suite of activists, drugmakers


    and policymakers has advocated for the re-
    classification of psilocybin and MDMA,
    which are currently Schedule I substances,
    meaning they have “no currently accepted
    medical use and a high potential for
    abuse.” The Controlled Substances Act was
    enacted in 1970 separating substances into
    five schedules, with Schedule I being the
    most serious.

    Sens. Cory Booker (D-NJ) and Rand Paul


    (R-KY) introduced a bill in November
    which would allow the federal Drug En-
    forcement Administration to make the nec-
    essary findings to reclassify therapies such
    as MDMA or psilocybin as Schedule II
    drugs, which are still characterized as hav-
    ing a high risk of abuse, though they in-
    clude medicines such as OxyContin and
    Dilaudid.

    RELATED: Congress takes another look at re-


    classifying psilocybin and MDMA

    When it comes to clinical


    trial design, MindMed
    CEO Robert Barrow said
    controlled substance reg-
    ulations impose “an addi-
    Robert Barrow tional barrier on top of an
    already extremely rigor-
    ous process.” His compa-
    ny’s lead product, a pharmacologically op-
    timized formation of LSD, is currently in a
    Phase IIb trial for generalized anxiety dis-
    order.

    “I think there’s a very di"erent, clear dis-


    tinction between rescheduling a drug in or-
    der to facilitate its use and rescheduling it
    to facilitate its clinical research,” he said.

    Reclassifying certain therapies that contain


    Schedule I substances would “help facili-
    tate a phased rollout of these potentially
    lifesaving therapies via FDA-approved Ex-
    panded Access pilot programs,” the sena-
    tors said in November, and remove “regula-
    tory red tape and a series of bureaucratic
    hurdles,” Booker added.

    Seattle doctor and Univer-


    sity of Washington profes-
    sor Sunil Aggarwal took
    the fight to change psilo-
    cybin’s CSA status to fed-
    eral court last year. When Sunil Aggarwal
    he previously asked the
    DEA to reclassify psilocy-
    bin as a Schedule II substance, the agency
    responded that the FDA “has not articulat-
    ed any accepted medical use” for the drug.
    In October, he petitioned the Ninth Circuit
    Court of Appeals to review the DEA’s deci-
    sion, which remains ongoing.

    “It’s just onerous,” Aggarwal told End-


    points News on Wednesday. “You can man-
    age diversion and all those things without
    all that, just the same way we do with THC
    pills, which is Schedule III, or ketamine,
    which is Schedule III.”

    Two weeks ago, the FDA released new


    draft guidance on conducting clinical re-
    search with psychedelics such as psilocy-
    bin, which acknowledged that designing
    clinical studies to evaluate their safety and
    e!cacy “presents several unique chal-
    lenges.”

    AUTHOR

    Nicole DeFeudis
    Editor
    nicole@endpointsnews.com
    @Nicole_DeFeudis
    Nicole DeFeudis on LinkedIn

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