AbbVie has received approval from the US Food and Drug Administration (FDA) for VRAYLAR (cariprazine) as an adjunctive therapy to antidepressants for major depressive disorder (MDD) in adult patients.
Co-developed by AbbVie and Gedeon Richter, VRAYLAR is an oral, once-daily atypical antipsychotic drug, which is also approved for the treatment of schizophrenia in adults.
AbbVie said that the additional indication of the drug offers a new option for adults with partial response to antidepressant treatment.
The approval was based on data from the 3111-301-001 phase 3 randomised, double-blind, placebo-controlled, multi-centre trial that recruited 751 participants across different countries.
As per the findings, the drug with a 1.5mg dose per day of cariprazine plus antidepressant therapy (ADT) showed a clinically and statistically significant variation from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo plus ADT.
Additionally, treatment with 2-4.5 mg/day + ADT showed a clinically and statistically significant change from baseline to week eight in the MADRS total score compared with placebo + ADT.
According to the biopharmaceutical firm, Cariprazine was also well tolerated in 6- and 8-week studies.
AbbVie chief scientific officer Thomas Hudson said: “Many living with major depressive disorder find that their ongoing antidepressant therapy doesn’t offer meaningful relief from the symptoms they experience every day.
“Today’s approval of VRAYLAR provides an important new treatment option to meet a critical unmet medical need. AbbVie is committed to driving progress and advancing solutions for patients living with complex neuropsychiatric conditions.”
In addition, the US-based biopharmaceutical firm has filed a supplemental new drug application (sNDA) for linaclotide ((LINZESS) to the FDA for the treatment of children between six to 17 years of age with functional constipation (FC).
LINZESS is indicated for the treatment of adults with both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC), AbbVie added.
The sNDA application for the new indication is based on the findings from a phase three clinical trial, which met both the primary and secondary endpoints. The late-stage trial evaluated linaclotide for increased frequency of spontaneous bowel movements (SBM) and improvement in stool consistency.
