The U.S. Food and Drug Administration (FDA) announced on Friday its rejection of MDMA as a treatment for post-traumatic stress disorder (PTSD). The decision was based on “significant limitations” that “prevent the agency from concluding that the drug is safe and effective for the proposed indication,” the FDA stated, as reported by the Associated Press….
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News FDA Declines to Approve MDMA Therapy, and Seeks Further Study
The agency said there was insufficient data to allow the use of a treatment for PTSD that involves the drug known as Ecstasy, according to the company seeking approval. Related Posts New Gene Editing Treatment Cuts Dangerous Cholesterol in Small Study The handful of patients had severe heart disease that had caused chest pain and…
0 20 0August 10, 2024 -
News Veterans advocate for MDMA, known as ecstasy, to be used in therapy to treat PTSD
In what could be a pivotal moment for the future of psychedelic medicine, the Food & Drug Administration (FDA) is weighing a decision to approve MDMA-AT, also known as ecstasy or molly, to treat post-traumatic stress disorder. The FDA is expected to make a decision by Aug. 11. The decision will have a huge impact…
0 22 0August 9, 2024 -
News Veterans and Lawmakers Lobby for Approval of MDMA Therapy
The F.D.A. is poised to rule on the therapeutic use of the club drug Ecstasy, a potential watershed moment in the nascent field of psychedelic medicine. Related Posts UK House of Commons votes against cease-fire amendment, over 50 labour lawmakers go against leader Members of Parliament in the United Kingdom House of Commons voted against…
0 26 0August 8, 2024 -
News FDA Panel Rejects Use of MDMA for Treatment of PTSD
An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting the unparalleled regulatory challenges of a novel therapy using the drug commonly known as Ecstasy. Before the vote, members of the panel raised concerns about the designs of the two studies submitted…
0 51 0June 4, 2024 -
News FDA Reviews MDMA Therapy for PTSD, Citing Health Risks and Study Flaws
The Food and Drug Administration on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company’s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition. The agency said that bias had seeped into the…
0 52 0May 31, 2024