[{"orgOrder":0,"company":"Sunovion Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New England Journal of Medicine Publishes Pivotal Results Evaluating Sunovion\u2019s SEP-363856 for the Treatment of Schizophrenia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Sunovion Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sunovion Ditches Once-Rejected ADHD, Binge Eating Program","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 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Find Clinical Drug Pipeline Developments & Deals by Sunovion Pharmaceuticals
SEP-363856 (ulotaront) is a TAAR1 agonist with 5-HT1A agonist activity, is currently under investigation for the treatment of schizophrenia, generalized anxiety disorder and the adjunctive treatment of MDD with additional indications under consideration.
Ulotaront (SEP-363856), a TAAR1 agonist with 5-HT1A agonist activity, is currently under investigation for the treatment of schizophrenia as well as the adjunctive treatment of MDD, with additional indications under consideration.
The acquisition of Brovana® (arformoterol tartrate) Inhalation Solution and Xopenex HFA® (levalbuterol tartrate) Inhalation Aerosol brands expands Lupin’s portfolio of inhalation products in the U.S. and strengthens the company’s presence in the respiratory therapy area.
Sep-4199, enhance 5-HT7 receptor antagonist activity and reduce dopamine D2 receptor antagonist activity is in SEP380-301, Phase 3 clinical development for treatment of major depressive episodes associated with bipolar I disorder also showed positive Phase 2 clinical result.
The collaboration will focus on solutions to address areas of unmet medical need by advancing four promising compounds―ulotaront (SEP-363856), SEP-4199, SEP-378614 and SEP-380135―that address serious neuropsychiatric disorders.
Under the terms of the agreement, BIAL will be responsible for regulatory approvals and submissions, including interactions with the European Medicines Agency (EMA) for APL-130277, which is currently in Phase 3 clinical development in Europe.
Latuda becomes the first 2nd generation antipsychotic to be approved for patients suffering from schizophrenia as young as 13 years of age. In addition to the new indication, Latuda was also granted an additional year of marketing protection.
Under the terms of the agreement, Sunovion will deploy its multi-specialty sales force to bring vibegron to primary care physicians (PCP). In support of this effort, Sunovion will provide sales and marketing activities targeting the PCP segment through March 31, 2026.
Sunovion Pharmaceuticalsannounced today that Health Canada has approved KYNMOBI™ (apomorphine HCI) soluble film for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD).
In a Phase 3 study, patients with Parkinson’s disease treated with KYNMOBI experienced significant improvements in motor symptoms at 30 minutes, compared to placebo.