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Society","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Alkermes Plc"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes to Showcase Data From Psychiatry Portfolio at Upcoming Scientific Conferences Throughout Mental Health Awareness Month","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Alkermes Plc"}]

Find Psychiatry/Psychology Drugs in Phase III Clinical Development in IRELAND

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            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.

            Lead Product(s): Cariprazine Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: Vraylar

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 23, 2022

            Abbvie Company Banner

            TMF Summit 2024

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            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.

            Lead Product(s): Cariprazine Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: Vraylar

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 22, 2022

            Abbvie Company Banner

            TMF Summit 2024

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            VRAYLAR® (cariprazine), a partial agonist at dopamine D3, D2, and serotonin 5-HT1A receptors used as atypical antipsychotic, met its primary endpoint demonstrating statistically significant change from baseline to week six in MADRS total score in major depressive disorder.

            Lead Product(s): Cariprazine Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: Vraylar

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 29, 2021

            Abbvie Company Banner

            TMF Summit 2024

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            Highlights of the presentations include: A clinical overview of olanzapine/samidorphan (LYBALVI™), formerly referred to as ALKS 3831, consisting of 18 clinical studies, evaluating LYBALVI's antipsychotic efficacy and weight mitigation profile along with its safety data.

            Lead Product(s): Olanzapine,Samidorphan L-Malate

            Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 03, 2021

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            The company's presentations included new exploratory analyses from the phase 3 ENLIGHTEN-2 study of olanzapine/samidorphan (LYBALVI™), formerly referred to as ALKS 3831.

            Lead Product(s): Olanzapine,Samidorphan L-Malate

            Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 20, 2021

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            U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder.

            Lead Product(s): Samidorphan L-Malate,Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 29, 2020

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            The AdCom will likely question whether or not ALKS-3831, a formulation of samidorphan and generically available olanzapine, provided a clinically meaningful reduction in the common weight gain side effect versus olanzapine.

            Lead Product(s): Samidorphan L-Malate,Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 17, 2020

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            The committees voted 16-1 that samidorphan meaningfully mitigates olanzapine-associated weight gain and also ruled that the safety profile of the drug has been adequately characterised by 13-3.

            Lead Product(s): Samidorphan L-Malate,Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 09, 2020

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            ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.

            Lead Product(s): Samidorphan L-Malate,Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 07, 2020

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            The company presented six posters, one of which focused on new outcomes research that analyzed treatment challenges of second-generation antipsychotics, such as weight gain and treatment interruptions, in patients living with schizophrenia or bipolar I disorder.

            Lead Product(s): Samidorphan L-Malate,Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 14, 2020

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