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Sunovion and Otsuka Initiate Phase 3 Clinical Development of Treatment for Bipolar Depression AmericanPharmaceuticalReview
February 10, 2022
Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. announced that the first patient has been randomized in SEP380-301...
Funding to support trial of ketamine in patients with bipolar depression europeanpharmaceuticalreview
June 22, 2021
The Canadian Government is funding studies to establish ketamine as a safe and effective treatment for patients with bipolar depression.
Intra-Cellular Therapies Applies for FDA Approval of CAPLYTA for Bipolar Depression americanpharmaceuticalreview
February 25, 2021
Intra-Cellular Therapies has recently submitted supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for two indications for CAPLYTA (lumateperone): 1) as monotherapy; and 2) as adjunctive therapy with lithium or ...
Intra-Cellular Therapies Announces Positive Results from Bipolar Depression Treatment Study americanpharmaceuticalreview
September 14, 2020
Intra-Cellular Therapies announced positive topline results from its Phase 3 clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or ...
FDA approves Allergan-Gedeon’s Vraylar to treat bipolar depression pharmaceutical-technology
May 31, 2019
Allergan and Gedeon Richter have secured US Food and Drug Administration (FDA) approval for the use of Vraylar (cariprazine) to treat bipolar I disorder.
FDA Grants Sunovion’s Latuda Expanded Approval for Bipolar Depression in Pediatric Patients biospace
March 07, 2018
There is a newly approved treatment for pediatric patients with major depressing episodes associated with bipolar disorder.
Light Therapy might help in the treatment of bipolar depression biospectrumasia
November 28, 2017
Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks, according to the National institute of Mental Health.
NeuroRx Awarded Fast Track Designation for Regimen Targeting Suicide in Bipolar Depression americanpharmaceuticacreview
September 07, 2017
NeuroRx has been granted Fast Track status by the U.S. Food and Drug Administration (FDA) for its sequential therapy of NRX-100 (ketamine HCl) followed by NRX-101 (D-cycloserine + lurasidone).
Sunovion Announces FDA Acceptance for Review of sNDA for Latuda for Bipolar Depression americanpharmaceuticalreview
July 04, 2017
Sunovion Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the expanded use of Latuda (lurasidone HCI) in children...