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    From Spinal Tap II to Ed Sheeran : your complete entertainment guide to the week ahead – The Guardian

    Fall’s Hottest Ski Films Are Going on Tour—Here’s the List – yahoo.com

    Experience the Thrill: Fall’s Hottest Ski Films Hit the Road-Don’t Miss the Tour!

    Ryan Reynolds reveals he called a journalist who said mean things about John Candy – yahoo.com

    Ryan Reynolds Reveals the Moment He Stood Up to a Journalist Who Insulted John Candy

    Entertainment Community Fund Launches Program Supporting Entrepreneurs – Playbill

    Entertainment Community Fund Unveils Exciting New Program to Empower Entrepreneurs

    Behind the turntables: DJ Johnny Kage’s story of perseverance – yahoo.com

    Behind the Turntables: DJ Johnny Kage’s Inspiring Journey of Perseverance

    The other WWE star James Gunn wanted for Peacemaker instead of John Cena – yahoo.com

    The WWE Star James Gunn Originally Wanted for Peacemaker Instead of John Cena

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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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    Unlocking AI Success: How People, Process, and Technology Form the Ultimate Triangle

    Billion-dollar coffins? New technology could make oceans transparent and Aukus submarines vulnerable – The Guardian

    Billion-Dollar Coffins? How New Technology Could Make Oceans Transparent and Expose Submarines

    What if artificial intelligence is just a “normal” technology? – The Economist

    What if artificial intelligence is just a “normal” technology? – The Economist

    Lincoln Trail College Receives $100,000 Grant from Marathon Petroleum Corporation for Technology Center – wwbl.com

    Lincoln Trail College Lands $100,000 Grant from Marathon Petroleum to Elevate Technology Center

    Aston Martin to integrate Pirelli’s cyber tyre technology in future models – Just Auto

    Aston Martin to Revolutionize Future Models with Pirelli’s Cutting-Edge Cyber Tyre Technology

    Figure Technology’s stock sizzles after IPO, as investors stay hungry for crypto deals – MarketWatch

    Figure Technology’s Stock Skyrockets After IPO Amid Surging Crypto Investor Excitement

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    From Spinal Tap II to Ed Sheeran : your complete entertainment guide to the week ahead – The Guardian

    Fall’s Hottest Ski Films Are Going on Tour—Here’s the List – yahoo.com

    Experience the Thrill: Fall’s Hottest Ski Films Hit the Road-Don’t Miss the Tour!

    Ryan Reynolds reveals he called a journalist who said mean things about John Candy – yahoo.com

    Ryan Reynolds Reveals the Moment He Stood Up to a Journalist Who Insulted John Candy

    Entertainment Community Fund Launches Program Supporting Entrepreneurs – Playbill

    Entertainment Community Fund Unveils Exciting New Program to Empower Entrepreneurs

    Behind the turntables: DJ Johnny Kage’s story of perseverance – yahoo.com

    Behind the Turntables: DJ Johnny Kage’s Inspiring Journey of Perseverance

    The other WWE star James Gunn wanted for Peacemaker instead of John Cena – yahoo.com

    The WWE Star James Gunn Originally Wanted for Peacemaker Instead of John Cena

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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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    • Trump Inauguration
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    Unlocking AI Success: How People, Process, and Technology Form the Ultimate Triangle

    Billion-dollar coffins? New technology could make oceans transparent and Aukus submarines vulnerable – The Guardian

    Billion-Dollar Coffins? How New Technology Could Make Oceans Transparent and Expose Submarines

    What if artificial intelligence is just a “normal” technology? – The Economist

    What if artificial intelligence is just a “normal” technology? – The Economist

    Lincoln Trail College Receives $100,000 Grant from Marathon Petroleum Corporation for Technology Center – wwbl.com

    Lincoln Trail College Lands $100,000 Grant from Marathon Petroleum to Elevate Technology Center

    Aston Martin to integrate Pirelli’s cyber tyre technology in future models – Just Auto

    Aston Martin to Revolutionize Future Models with Pirelli’s Cutting-Edge Cyber Tyre Technology

    Figure Technology’s stock sizzles after IPO, as investors stay hungry for crypto deals – MarketWatch

    Figure Technology’s Stock Skyrockets After IPO Amid Surging Crypto Investor Excitement

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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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The Market Isn’t Lagging – It’s Distorted: Why Investors Must Stop Treating the S&P as the Economy’s Crystal Ball – MSN

The Market Isn’t Lagging – It’s Distorted: Why Investors Must Stop Treating the S&P as the Economy’s Crystal Ball – MSN

September 15, 2025

From Spinal Tap II to Ed Sheeran : your complete entertainment guide to the week ahead – The Guardian

September 15, 2025
A multibillion-dollar oil project is impacting locals’ health and livelihood in Uganda – NPR

Multibillion-Dollar Oil Project Threatens Health and Livelihoods of Ugandan Communities

September 15, 2025
Politics chat: Assassination of Charlie Kirk and the rise of political violence – NPR

The Alarming Rise in Political Violence and the Threat Facing Charlie Kirk

September 15, 2025
Washington takes on flawed federal climate report – NewsRadio 560 KPQ

Washington Challenges Key Flaws in Federal Climate Report

September 14, 2025
James Webb telescope’s ‘starlit mountaintop’ could be the observatory’s best image yet — Space photo of the week – Live Science

James Webb Telescope Unveils Stunning ‘Starlit Mountaintop’ – Perhaps Its Most Breathtaking Image Yet

September 14, 2025

Colby College Announces Exciting New $150 Million Science Facility Funded by Anonymous Donor

September 14, 2025
Maine Coon Cat’s Sweet Love Story With Tiny Sphynx Kitty Is Touching Hearts – yahoo.com

Adorable Maine Coon and Tiny Sphynx Share a Heartwarming Love Story

September 14, 2025

Unlocking AI Success: How People, Process, and Technology Form the Ultimate Triangle

September 14, 2025
Transgender student who challenged Idaho sports ban drops lawsuit – KTVB

Transgender student who challenged Idaho sports ban drops lawsuit – KTVB

September 14, 2025

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The Market Isn’t Lagging – It’s Distorted: Why Investors Must Stop Treating the S&P as the Economy’s Crystal Ball – MSN

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September 15, 2025

From Spinal Tap II to Ed Sheeran : your complete entertainment guide to the week ahead – The Guardian

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