By CCHR National
The U.S. drug regulatory agency examined evidence presented by the company requesting approval for MDMA (ecstasy) and reports from experts examining that evidence before denying approval for the drug as mental health treatment. A medical journal has just retracted three MDMA therapy research papers for ethical violations.
Washington, DC – August 13, 2024 — The U.S. Food and Drug Administration (FDA) has rejected the psychedelic drug MDMA, commonly known as ecstasy or molly, as treatment for post-traumatic stress, a decision that Citizens Commission on Human Rights (CCHR) advocated in its statement submitted to the FDA during a public comment period earlier this year. The FDA’s decision ends the first attempt to gain the agency’s approval for a psychedelic drug treatment.
The FDA concurred with the findings of its advisory committee of independent experts, which held a public hearing in June on the use of MDMA for psychedelic-assisted psychotherapy. The committee voted overwhelmingly that the company which applied for drug approval, Lykos Therapeutics, failed in its clinical trials to prove the treatment was effective, and that benefits from the drug therapy did not outweigh the risks. READ MORE
