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FDA Rejects MDMA-Assisted Therapy For PTSD
The FDA has rejected a first-of-its-kind proposal to use the psychedelic drug MDMA as a treatment for post-traumatic stress disorder (PTSD), according to drugmaker Lykos Therapeutics. NBC News reports: There had been intense political pressure on the FDA to approve the drug. Friday's decision was t...
The FDA has rejected a first-of-its-kind proposal to use the psychedelic drug MDMA as a treatment for post-traumatic stress disorder (PTSD), according to drugmaker Lykos Therapeutics. The agency's decision came after an independent advisory committee in June declined to recommend approval of the drug, saying there was not enough evidence that the therapy was safe and effective. A review by FDA scientists, published ahead of the June meeting, also raised concerns about how the trials were carried out, including that a number of patients and therapists likely were able to guess who was given the medication and who got the placebo.
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