* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Wednesday, June 25, 2025
Earth-News
  • Home
  • Business
  • Entertainment
    George Lopez is coming to Spokane – KXLY.com

    George Lopez is coming to Spokane – KXLY.com

    Netflix unveils Dallas immersive venue for fans of hit shows like ‘Squid Game,’ ‘Stranger Things’ – Houston Chronicle

    Step Inside Netflix’s New Dallas Immersive Experience Featuring Hits Like ‘Squid Game’ and ‘Stranger Things

    ‘Puttin’ on the Ritz’: Civic Players bring ‘Young Frankenstein’ to life – Yahoo

    Civic Players Deliver a Hilarious and Unforgettable Performance of ‘Young Frankenstein

    ‘Wheel of Fortune’: Amputee Wins $60,000 After Breaking Incredible ‘Curse’ – Hastings Tribune

    Wheel of Fortune’ Amputee Breaks Incredible ‘Curse’ to Win $60,000!

    North Star Sports & Entertainment Network: Coming soon – KTTC News

    North Star Sports & Entertainment Network: Coming soon – KTTC News

    Safety concerns in Deep Ellum create apprehension as the entertainment district gains visitors – CBS News

    Safety Concerns Surge Amid Deep Ellum’s Booming Popularity and Growing Crowds

  • General
  • Health
  • News

    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

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Frontdoor Announces Tech Expert Dr. Bala Ganesh as Chief Technology Officer – Business Wire

    Frontdoor Appoints Tech Visionary Dr. Bala Ganesh as New Chief Technology Officer

    Defense technology giant Northrop Grumman to host interviews in Iuka to fill technician roles – supertalk.fm

    Defense technology giant Northrop Grumman to host interviews in Iuka to fill technician roles – supertalk.fm

    China’s Military Introduces Mosquito-Sized Drones: A Game-Changing Surveillance Technology – Indian Defence Review

    China Unveils Mosquito-Sized Drones: Revolutionizing Surveillance Technology

    Marvell Technology Stock Rallies After AI Event Sparks Investor Optimism – Yahoo Finance

    Marvell Technology Stock Rallies After AI Event Sparks Investor Optimism – Yahoo Finance

    Promising Technology Stocks To Follow Today – June 22nd – MarketBeat

    Top Technology Stocks to Watch Today – June 22nd

    Technology Convergence Report 2025 – The World Economic Forum

    Technology Convergence Report 2025 – The World Economic Forum

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment
    George Lopez is coming to Spokane – KXLY.com

    George Lopez is coming to Spokane – KXLY.com

    Netflix unveils Dallas immersive venue for fans of hit shows like ‘Squid Game,’ ‘Stranger Things’ – Houston Chronicle

    Step Inside Netflix’s New Dallas Immersive Experience Featuring Hits Like ‘Squid Game’ and ‘Stranger Things

    ‘Puttin’ on the Ritz’: Civic Players bring ‘Young Frankenstein’ to life – Yahoo

    Civic Players Deliver a Hilarious and Unforgettable Performance of ‘Young Frankenstein

    ‘Wheel of Fortune’: Amputee Wins $60,000 After Breaking Incredible ‘Curse’ – Hastings Tribune

    Wheel of Fortune’ Amputee Breaks Incredible ‘Curse’ to Win $60,000!

    North Star Sports & Entertainment Network: Coming soon – KTTC News

    North Star Sports & Entertainment Network: Coming soon – KTTC News

    Safety concerns in Deep Ellum create apprehension as the entertainment district gains visitors – CBS News

    Safety Concerns Surge Amid Deep Ellum’s Booming Popularity and Growing Crowds

  • General
  • Health
  • News

    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

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Frontdoor Announces Tech Expert Dr. Bala Ganesh as Chief Technology Officer – Business Wire

    Frontdoor Appoints Tech Visionary Dr. Bala Ganesh as New Chief Technology Officer

    Defense technology giant Northrop Grumman to host interviews in Iuka to fill technician roles – supertalk.fm

    Defense technology giant Northrop Grumman to host interviews in Iuka to fill technician roles – supertalk.fm

    China’s Military Introduces Mosquito-Sized Drones: A Game-Changing Surveillance Technology – Indian Defence Review

    China Unveils Mosquito-Sized Drones: Revolutionizing Surveillance Technology

    Marvell Technology Stock Rallies After AI Event Sparks Investor Optimism – Yahoo Finance

    Marvell Technology Stock Rallies After AI Event Sparks Investor Optimism – Yahoo Finance

    Promising Technology Stocks To Follow Today – June 22nd – MarketBeat

    Top Technology Stocks to Watch Today – June 22nd

    Technology Convergence Report 2025 – The World Economic Forum

    Technology Convergence Report 2025 – The World Economic Forum

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
Earth-News
No Result
View All Result
Home Health

FDA Staff Questions Safety of MDMA Treatment for PTSD

June 1, 2024
in Health
FDA Staff Questions Safety of MDMA Treatment for PTSD
Share on FacebookShare on Twitter

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
>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : MedPageToday – https://www.medpagetoday.com/psychiatry/anxietystress/110423

Tags: healthquestionsstaff
Previous Post

FDA Approves First mRNA RSV Vaccine

Next Post

Guillain-Barre Syndrome Rates After RSV Shots in Sync With Trial Data, CDC Says

Frontdoor Announces Tech Expert Dr. Bala Ganesh as Chief Technology Officer – Business Wire

Frontdoor Appoints Tech Visionary Dr. Bala Ganesh as New Chief Technology Officer

June 25, 2025
City council approves Sports Illustrated Resort – WBRC 6 News

City Council Approves Exciting New Sports Illustrated Resort Project

June 25, 2025
MEPAG Search for Life – Science Analysis Group Science Community Virtual Workshops – astrobiology.com

MEPAG Search for Life – Science Analysis Group Science Community Virtual Workshops – astrobiology.com

June 25, 2025
Volusia County Marine Science Center reopens to the public – Spectrum News 13

Volusia County Marine Science Center Welcomes Visitors Once Again

June 25, 2025

Boss Lifestyle’ Ponzi Scheme Mastermind Admits Guilt in $23 Million Fraud Scandal

June 25, 2025
Exclusive | Stablecoin World Opens Up to Main Street Banks – WSJ

Exclusive | Stablecoin World Opens Up to Main Street Banks – WSJ

June 25, 2025
UK calls China a major challenge but an essential economic partner – AP News

UK Labels China a Major Challenge While Emphasizing Its Role as a Vital Economic Partner

June 25, 2025
George Lopez is coming to Spokane – KXLY.com

George Lopez is coming to Spokane – KXLY.com

June 25, 2025
Neera Tanden defends use of presidential autopen, denies covering up Biden’s health – WSYX

Neera Tanden Defends Use of Presidential Autopen, Rejects Claims of Concealing Biden’s Health Information

June 25, 2025
Blake Farenthold, 63, Congressman Who Quit in Harassment Case, Dies – The New York Times

Former Congressman Blake Farenthold, Who Resigned Amid Harassment Scandal, Dies at 63

June 25, 2025

Categories

Archives

June 2025
MTWTFSS
 1
2345678
9101112131415
16171819202122
23242526272829
30 
« May    
Earth-News.info

The Earth News is an independent English-language daily published Website from all around the World News

Browse by Category

  • Business (20,132)
  • Ecology (698)
  • Economy (716)
  • Entertainment (21,612)
  • General (15,556)
  • Health (9,755)
  • Lifestyle (721)
  • News (22,149)
  • People (718)
  • Politics (723)
  • Science (15,934)
  • Sports (21,213)
  • Technology (15,702)
  • World (696)

Recent News

Frontdoor Announces Tech Expert Dr. Bala Ganesh as Chief Technology Officer – Business Wire

Frontdoor Appoints Tech Visionary Dr. Bala Ganesh as New Chief Technology Officer

June 25, 2025
City council approves Sports Illustrated Resort – WBRC 6 News

City Council Approves Exciting New Sports Illustrated Resort Project

June 25, 2025
  • About
  • Advertise
  • Privacy & Policy
  • Contact

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

Go to mobile version