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The FDA Rejects MDMA…What Now? | Kennedy Saves The World

After much deliberation, this week a panel of experts advising the Food and Drug Administration voted against the approval of therapy-guided MDMA for treating PSTD. Kennedy criticizes the panel for prohibiting PSTD patients from getting effective treatment and highlights the success of studies and c

Drug administrationMultidisciplinary association for psychedelic studiesMultidisciplinary associationPsychedelic studies

FDA Advisory Panel Votes Against Using MDMA Drug Ecstasy as Treatment for PTSD

FDA advisors cited concerns over clinical data, selection and expectation bias, and the safety risks of MDMA.

United statesMichael abramsMaryann amirshahiPaul holtzheimerKim witczakBrian dempseyJonathan alpertElizabeth joniakDrug administrationBehavioral sciencesAmerican psychiatric associationPsychopharmacologic drugs advisory committeeNational centerDepartment of psychiatryAlbert einstein college of medicineMultidisciplinary association for psychedelic studies

FDA Panel Rejects MDMA-Assisted Therapy For PTSD

An FDA advisory panel has recommended that the agency not approve the use of MDMA-assisted therapy as a treatment for PTSD.

United statesBerra yazar klosinskiElizabeth joniakAmy emersonMelissa baroneShawn hauserMultidisciplinary association for psychedelic studiesWashington postPsychopharmacologic drugs advisory committeePanel cites concerns withDrug administrationInstitute for clinicalVa maryland health care systemLykos therapeuticsMultidisciplinary associationPsychedelic studies

FDA Advisers Overwhelmingly Oppose Approval of MDMA As a Psychotherapeutic Catalyst

FDA Advisers Overwhelmingly Oppose Approval of MDMA As a Psychotherapeutic Catalyst
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Rick doblinAlexander shulginDavid millisJerry rosenbaumMelissa decker baroneAmy emersonInstitute for clinicalDrug administrationMultidisciplinary association for psychedelic studiesDrug enforcement administrationDepartment of veterans affairsLykos therapeuticsMultidisciplinary associationPsychedelic studiesVeterans affairsNature medicine

FDA Advisers Overwhelmingly Oppose Approval of MDMA As a Psychotherapeutic Catalyst

The panel's recommendation, based on several concerns about two clinical trials, is a serious setback for a promising PTSD treatment.

David millisMelissa decker baroneRick doblinAlexander shulginJerry rosenbaumAmy emersonDepartment of veterans affairsMultidisciplinary association for psychedelic studiesDrug administrationInstitute for clinicalDrug enforcement administrationLykos therapeuticsMultidisciplinary associationPsychedelic studiesVeterans affairsNature medicine