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• W2983463140 abstract "In March, 2019, the US Food and Drug Administration (FDA) approved two new antidepressants: esketamine for treatment-resistant depression 1 US Food and Drug AdministrationBriefing Information for the February 12, 2019 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM). https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM630970.pdfDate accessed: April 16, 2019 Google Scholar and brexanolone for postpartum depression. 2 US Food and Drug AdministrationBriefing Information for the November 2, 2018 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM). https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM624643.pdfDate accessed: April 16, 2019 Google Scholar Both had the breakthrough designation, an expedited review process for drugs “intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)”. 3 US Food and Drug AdministrationBreakthrough therapy. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapyDate accessed: June 15, 2019 Google Scholar Although new interventions are welcome for these debilitating disorders, we are concerned that these approvals share common critical features, and could further lower the bar in the evaluation of treatments for mental disorders. Esketamine for treatment-resistant depression: seven concerns about efficacy and FDA approvalWith a novel mechanism of action compared with existing marketed antidepressants, esketamine has been of keen interest to mental health clinicians and researchers. On March 5, 2019, the US Food and Drug Administration (FDA) approved intranasal esketamine for treatment-resistant depression.1 To make a proper risk–benefit analysis before prescribing, mental health clinicians should look beyond the fact of approval and consider the data from the phase 3 clinical trials, which are freely available in the public domain in the form of the slides and briefing documents from the Feb 12, 2019, Psychopharmacologic Drugs Advisory Committee. Full-Text PDF Approval of esketamine for treatment-resistant depressionWe acknowledge the questions raised by Erick Turner1 and by Ioana Cristea and Florian Naudet2 in The Lancet Psychiatry regarding esketamine's efficacy and the study designs within the phase 3 programme in treatment-resistant depression, and here provide clarification. Full-Text PDF In with the new?The turn of the year is a point of endings and beginnings, a concept that the ancient Romans embodied as the god Janus. Janus had two faces, and hence the enviable ability to see into both the past and the future: something that would be a prized asset in the world of psychiatric practice and research. Dwelling on the failures of the past can impede belief in, and motivation towards, future progress, while uncritical hype surrounding new treatments might put the profession at risk of repeating old mistakes. Full-Text PDF" @default.
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• W2983463140 title "US Food and Drug Administration approval of esketamine and brexanolone" @default.
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• W2983463140 doi "https://doi.org/10.1016/s2215-0366(19)30292-5" @default.
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