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    Simpson College to purchase medical simulation technology with grant funds – Iowa Capital Dispatch

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    Kroger shares summer entertainment tips – Supermarket Perimeter

    Ultimate Summer Entertainment Tips to Make Your Season Unforgettable

    Theater at Santa Fe’s San Isidro Plaza will be converted into IMAX, family entertainment venue – Santa Fe New Mexican

    Santa Fe’s San Isidro Plaza Theater Transforms into Exciting IMAX Family Entertainment Venue

    B&B Theatres will open massive entertainment complex in Texas – The Business Journals

    B&B Theatres will open massive entertainment complex in Texas – The Business Journals

    Rough times for broadcast networks illustrate changing media landscape – New Haven Register

    Broadcast Networks Confront Turbulent Times in a Rapidly Changing Media Landscape

    Black River Entertainment Adds Traci Hite As Director Of Promotion, Southeast – MusicRow.com

    Black River Entertainment Welcomes Traci Hite as New Director of Southeast Promotion

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    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

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    Polypurine Hairpin Technology is Safe, Effective at Inhibiting PCSK9 to Regulate Cholesterol – Pharmacy Times

    Polypurine Hairpin Technology: A Safe and Powerful Breakthrough for Controlling Cholesterol by Targeting PCSK9

    A major AI training data set contains millions of examples of personal data – MIT Technology Review

    A major AI training data set contains millions of examples of personal data – MIT Technology Review

    Simpson College to purchase medical simulation technology with grant funds – Iowa Capital Dispatch

    Simpson College to purchase medical simulation technology with grant funds – Iowa Capital Dispatch

    SailGP Technologies officially launches new center of excellence in technology & innovation – Sail-World.com

    SailGP Technologies officially launches new center of excellence in technology & innovation – Sail-World.com

    Victorville’s new gunfire-detecting technology already making strides, city says – NBC Los Angeles

    Victorville’s New Gunfire-Detecting Technology Is Already Making a Difference, City Officials Say

    Guest columnist: China cutting corners on technology – The State Journal

    China’s Rapid Tech Advances Spark Worries About Cutting Corners

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FDA Staff Questions Safety of MDMA Treatment for PTSD

June 1, 2024
in Health
FDA Staff Questions Safety of MDMA Treatment for PTSD
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FDA staff raised concerns about the available safety data and limitations in the study design for midomafetamine (MDMA) to treat post-traumatic stress disorder (PTSD) in briefing documents released ahead of an FDA Psychopharmacologic Drugs Advisory Committee (PDAC) meeting.

If eventually approved by the agency, Lykos Therapeutics’ MDMA could become a first-in-class treatment for PTSD, which affects an estimated 5% of the U.S. population in any given year, according to the Veterans’ Administration National Center for PTSD. While PTSD can be treated with selective serotonin reuptake inhibitors (SSRIs), FDA staff noted that response rates with these drugs rarely exceed 60%, and typically less than 20% to 30% of patients achieve full remission.

“Thus, there remains an unmet need for additional options for safe and effective therapies to treat PTSD,” the FDA reviewers wrote.

The agency will ask the PDAC to discuss several major points during the June 4 meeting. The committee will first focus on efficacy, including the potential effect of functional unblinding on the interpretability of efficacy results, the durability of effects, and the role of psychotherapy in the treatment paradigm. It will assess the adequacy of the safety characteristics of MDMA, and review the potential for patient impairment or serious harm from treatment. In addition, the PDAC will weigh in on a proposed risk mitigation strategy to prevent serious patient harms related to MDMA treatment.

Two phase III trials conducted have assessed the efficacy and safety of MDMA in PTSD. Both studies, MAPP1 and MAPP2, were randomized, double-blind, placebo-controlled trials that included 91 and 104 participants with PTSD, respectively. Participants received three dosing sessions of MDMA with additional psychological support sessions before and after dosing.

In both trials, the MDMA arm experienced statistically significantly greater improvement in PTSD symptoms based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score.

In MAPP1, the MDMA and psychotherapy group saw an average drop in CAPS-5 score of 24.4 points, while those receiving psychotherapy alone saw an average drop of 13.9 points. In MAPP2, patients in the MDMA arm had a least-squares mean change of -23.7 in CAPS-5 score compared with -14.8 for those in the placebo arm (P
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