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FDA grants priority review to MDMA-assisted therapy for PTSD

FDA grants priority review to MDMA-assisted therapy for PTSD
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Shenaz baghaAmy emersonSheehan disability

MDMA-Assisted Therapy for PTSD Awaits FDA Decision

Jennifer Mitchell, PhD, discusses MAPS Public Benefit Corporations’ recent New Drug Application submission for MDMA-Assisted Therapy for PTSD and what the treatment’s potential approval could mean for people with PTSD.

United statesSan franciscoSteve levineJennifer mitchellPatient access medical affairsUniversity of californiaMaps public benefit corporationUs food drug administrationDrug enforcement administrationBenefit corporationNew drug applicationDrug administrationAssisted therapySheehan disabilityPatient accessMedical affairs

MAPS PBC Submits NDA to the FDA for MDMA-Assisted Therapy for PTSD

An FDA approval of MDMA-assisted therapy would require the DEA to reschedule MDMA in acknowledgement of its medical use, making it available for prescription medical use.

United statesAmy emersonCody shandrawHealing realtyMultidisciplinary association for psychedelic studiesPublic benefit corporationMultidisciplinary associationPsychedelic studiesBreakthrough therapySheehan disabilityControlled substances actCambria capital

Axsome Therapeutics to Present Data and Post-Hoc Analyses on Auvelity® and Sunosi® at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Data on Auvelity demonstrating improved functioning in major depressive disorder Data on Sunosi demonstrating improved cognitive function in patients with excessive daytime sleepiness associated with. | May 30, 2023

United statesNew yorkGregory mattinglyRakesh jainEileen learyAndrew cutlerSamantha floamDarren oplandZachariah thomasMark jacobsonClinical professor of psychiatry at washington universityAxsome therapeutics incMd texas tech university school of medicineWorld trade centerNational survey on drugSk biopharmaceuticals co ltd

Phase 3 Trial Evaluating MDMA-Assisted Therapy for PTSD Meets Endpoints

Positive results were announced from a phase 3 study evaluating MDMA-assisted psychotherapy in adults with at least moderate PTSD.

Amy emersonSheehan disability

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