Gepirone Under Review for Major Depressive Disorder
Exxua (previously named Travivo) is a novel oral serotonin 1A receptor agonist.
Exxua (previously named Travivo) is a novel oral serotonin 1A receptor agonist.
The approval was based on data from adequate and well-controlled studies with risperidone long-acting injection (intramuscular).
The sNDA is supported by data from two phase 3 studies that evaluated the efficacy and safety of brexpiprazole in patients with agitation associated with Alzheimer dementia.
The study included approximately 400 adults with a history of bipolar I disorder who had a current episode of mania.
The approval was based on data from 2 trials in adults who met DSM-IV-TR or DSM-5 criteria for MDD and had an inadequate response to 1 to 3 courses of prior antidepressant therapy.
The designation is supported by data from 3 clinical studies.
AXS-05 is an investigational agent consisting of a proprietary formulation of dextromethorphan and bupropion.
The trial compared Spravato (esketamine nasal spray) to quetiapine extended-release, both in combination with a continuing SSRI or SNRI.
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