– Submission is based on clinical trial results that include findings showing clinically and statistically significant improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients with major depressive disorder (MDD) treated with cariprazine (VRAYLAR®) and an antidepressant
– If approved, this milestone will be the fourth indication for cariprazine (VRAYLAR®) joining approvals for the treatment of adults with schizophrenia, the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of depressive episodes associated with bipolar I disorder
AbbVie (NYSE: ABBV) today announced that it has submitted a supplemental New Drug Application (sNDA) for cariprazine (VRAYLAR®) to the U.S. Food and Drug Administration (FDA) for the adjunctive treatment of major depressive disorder (MDD) in patients who are receiving ongoing antidepressant therapy. The submission is supported by results from previously announced clinical trials.
A Phase 3 Study 3111-301-001 showed a clinically and statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score for patients treated with cariprazine at 1.5 mg/day compared with placebo. A second registration-enabling study, RGH-MD-75, showed a clinically and statistically significant change from baseline to week eight in the MADRS total score for patients treated with cariprazine at 2-4.5 mg/day compared with placebo. In both of these studies, safety data were consistent with the established safety profile of cariprazine across indications, with no new safety events identified. Also supporting the submission is study RGH-MD-76 that examined the long-term safety and tolerability of cariprazine over 26 weeks.
“Many people living with major depressive disorder struggle to find a treatment that reduces their depressive symptoms, with many taking years to find the right treatment. Cariprazine, when added to ongoing antidepressant treatment in patients with major depressive disorder, demonstrated that it can reduce depressive symptoms,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We look forward to working closely with the FDA during the review of our submission to bring a potential new adjunctive therapy to patients with major depressive disorder who are taking an antidepressant and seeking additional relief. This submission demonstrates our strong commitment to addressing additional gaps in the care of people affected by psychiatric disorders.”
Cariprazine is marketed as VRAYLAR® in the United States and is FDA-approved to treat adults with depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia. Cariprazine is being co-developed by AbbVie and Gedeon Richter Plc. More than 8,000 patients worldwide have been treated with cariprazine across more than 20 clinical trials evaluating the efficacy and safety of cariprazine for a broad range of psychiatric disorders.
About Major Depressive Disorder (MDD)
MDD is one of the most common mental disorders in the United States. In 2020, an estimated 21 million adults had at least one major depressive episode. For some individuals, MDD can result in severe impairment which may interfere with or limit one’s daily activities.1 The World Health Organization lists depression as the third-leading cause of disability worldwide and as a major contributor to the overall global burden of disease. Symptoms can include depressed mood, loss of pleasure or interest in activities, changes in appetite or weight, changes in sleep, psychomotor retardation, loss of energy, feelings of worthlessness, indecisiveness, and recurrent thoughts of death.2 In the United States, the estimated economic burden of MDD has been estimated to be around $326 billion.3
About VRAYLAR® (cariprazine)
VRAYLAR is an oral, once-daily atypical antipsychotic approved for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder (3 to 6 mg/day) and for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults (1.5 or 3 mg/day). VRAYLAR is also approved for the treatment of schizophrenia in adults (1.5 to 6 mg/day). Use of VRAYLAR in adjunctive treatment of major depressive disorder is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
About AbbVie in Mental Health
AbbVie is driving the pursuit of better mental health. Over the last 30 years, the company’s scientists and clinicians have worked to tackle the complexity of mental illness and today offer a portfolio of medicines and a pipeline of innovation that spans depression, anxiety, bipolar I disorder, and schizophrenia. To learn more about AbbVie’s work to support individuals throughout their mental health journey, please visit www.abbvie.com or follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.