The supplemental New Drug Application approval was based on data from 3 trials (RGH-MD-53, RGH-MD-54 and RGH-MD-56) in which cariprazine was associated with greater improvement in change from baseline to week 6 on the Montgomery Asberg Depression Rating Scale (MADRS) total score vs placebo in patients who met DSM-IV-TR or DSM-5 criteria for depressive episodes associated with bipolar I disorder. Both the 1.5mg and 3mg dose demonstrated superiority over placebo. The most commonly reported adverse events reported in the trials were nausea, akathisia, restlessness and extrapyramidal symptoms.
“This approval represents an important milestone in our efforts to help patients and prescribing healthcare providers effectively manage bipolar I disorder and demonstrates our ongoing focus on mental health,” said David Nicholson, Chief Research & Development Officer at Allergan. “We are committed to developing therapies for complex mental health disorders, including Vraylar, which is currently in phase 3 clinical trials for the treatment of major depressive disorder.”
Vraylar, an atypical antipsychotic, is also approved for the treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
For more information visit vraylar.com.
This article originally appeared on MPR