FDA Cracks Down on MDMA Therapy Trials: Expanded Investigation Reveals New Issues! 🔍

News & Articles
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Summary:

  1. Expanded Investigation
    The FDA is broadening its probe into MDMA-based therapy trials for PTSD, even after rejecting the drug earlier this month. Investigators are now interviewing more individuals to assess if side effects were underreported.

  2. Serious Allegations
    Concerns include undocumented adverse effects, such as suicidal thoughts, and claims that participants were discouraged from reporting issues. The trials also faced criticism for alleged sexual misconduct and trial design flaws.

  3. Company Troubles
    Following the FDA’s rejection, the company Lykos is laying off 75% of its staff and overhauling leadership. Additionally, a scientific journal has retracted three of Lykos’s studies due to “unethical conduct.”

Read more at: Ars Technica