U.S. Markets open in 4 hrs 16 mins

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

  • Oops!
    Something went wrong.
    Please try again later.
·1 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • AbbVie Inc (NYSE: 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.

See more from Benzinga

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.