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FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Sage Therapeutics"},{"orgOrder":0,"company":"Emergent BioSolutions","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Emergent BioSolutions Reports FDA Advisory Committees\u2019 Unanimous Vote in Favor of NARCAN\u00ae (naloxone HCI) Nasal Spray for Over-the-Counter Use","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Emergent 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Lundbeck AS","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on brexpiprazole for the Treatment of Agitation Associated with Alzheimer's Dementia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Otsuka Pharmaceutical"},{"orgOrder":0,"company":"Achieve Life Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Achieve Life Sciences Announces Positive Phase 2 ORCA-V1 Trial Results Showing Statistically Significant Vaping Cessation Benefit for Participants Treated with Cytisinicline","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase 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Study of Oral Weekly Risperidone (LYN-005) for Schizophrenia and Schizoaffective Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Lyndra Therapeutics"},{"orgOrder":0,"company":"Freya Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Freya Pharma Solutions Announces Advice from the FDA on its US Clinical Development Program of Lybrido\u2122 for the treatment of Female Sexual Interest\/Arousal Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Freya Pharma"},{"orgOrder":0,"company":"Minerva Neurosciences","sponsor":"Not 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Schizophrenia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"BioXcel Therapeutics"}]
Find Psychiatry/Psychology Drugs in Phase III Clinical Development
In Study 3111-301-001, cariprazine (VRAYLAR®; 1.5mg/day) achieved the primary endpoint of statistically significant improvement on MADRS total score in patients with major depressive disorder with an inadequate response to ongoing antidepressant therapy.
Submission based on clinical trial results findings showing clinically and statistically significant improvement in the Montgomery-Åsberg Depression Rating Scale total score in patients with major depressive disorder treated with VRAYLAR (cariprazine) and an antidepressant.
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