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 Rating Scale (MADRS) total score.
Last year, AbbVie announced that cariprazine met its primary endpoint in the Phase 3 Study 3111-301-001, which involved a statistically significant change from baseline at week six in the MADRS total score in MDD patients. Cariprazine recipients in that study received either 1.5 mg or 3.0 mg of the drug each day. Those who received the smaller dose demonstrated a statistically significant improvement in the MADRS score.
A second Phase 3 clinical trial known as Study 3111-302-001 also showed improvement in depressive symptoms at the same interval but did not reach statistical significance for either 1.5 mg or 3.0 mg doses of the drug.
AbbVie is partnering with Gedeon Richter in developing cariprazine.
LLY shares were down 0.53% to $239.03 in afternoon trading.
Filed Under: Psychiatric/psychotropic drugs