AbbVie's Major Depressive Disorder Candidate Shows Mixed Result In Late-Stage Trials

AbbVie Inc ABBV has announced topline results from two Phase 3 trials, Study 3111-301-001 and Study 3111-302-001, of cariprazine (Vraylar) as an adjunctive treatment for major depressive disorder (MDD).
In Study 3111-301-001, cariprazine showed a statistically significant change from baseline to week six on the depression severity scale, with cariprazine at 1.5 mg/day achieving an improved score compared to placebo.
Patients treated with cariprazine at 3.0 mg/day demonstrated improvement in the score at week six over placebo but did not meet statistical significance.
In Study 3111-302-001, cariprazine demonstrated numerical improvement in depressive symptoms compared with placebo but did not meet its primary endpoint for either the 1.5 mg/day or 3.0 mg/day dose.
On the safety front, the most common adverse events were akathisia, nausea, insomnia, headache, and somnolence.
Full results from studies will be presented at a future medical meeting.
Also Read: AbbVie Stock Gains After Hiking FY21 Earnings Outlook, Annual Dividend.
Price Action: ABBV shares are up 2.68% at $112.61 during the premarket session on the last check Friday.