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The FDA rejected an application for the drug MDMA, in combination with therapy, as treatment for PTSD on Friday.
Drugmaker Lykos Therapeutics had asked the FDA to approve its MDMA capsules as part of a therapy regimen they argued could be a breakthrough for treating challenging cases of PTSD. Lykos said the ...
The U.S. Food and Drug Administration (FDA) announced Friday its rejection of MDMA as a treatment for PTSD. The decision was based on "significant limitations" that "prevent the agency from ...
Dr. Brian Barnett, a psychiatrist who heads psychedelic research at the Cleveland Clinic in Ohio, also said he thinks MDMA will be eventually approved for PTSD, despite the FDA’s decision.
In June, the FDA's Psychopharmacologic Drugs Advisory Committeevoted 9-2 against MDMA as an effective treatment for PTSD patients, and 10-1 that the drug's benefits do not outweigh the risks.
Two small studies submitted to the FDA suggested combining MDMA with talk therapy led to significant easing of PTSD symptoms. Antidepressants are now the only FDA-approved drugs for PTSD ...
Opens in a new tab or window The FDA declined to approve midomafetamine (MDMA) capsules for post-traumatic stress disorder (PTSD), calling for another trial to evaluate the drug's efficacy and ...
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