AbbVie (NYSE: ABBV) has submitted a supplemental New Drug Application (sNDA) for cariprazine (Vraylar)for major depressive disorder (MDD).
FDA first approved cariprazine for schizophrenia and bipolar disorder in 2015. Current indications of the drug cover the acute treatment of manic or mixed episodes related to bipolar I disorder and depressive episodes associated with bipolar I disorder.
In its recent sNDA, AbbVie is attempting to secure approval of the drug as an adjunctive treatment with MDD who receive ongoing antidepressants.
Antidepressants are a cornerstone of treating depression, although experts are divided on the efficacy of antidepressants in general. One study published on InformedHealth.org found that antidepressants at large are roughly 20% more effective than placebo in treating depression.
In the submission, AbbVie included data on cariprazine recipients showing clinical improvements based on the Montgomery-Åsberg Depression Ratin…