FDA Approves New Adjunctive Treatment for Depression

Major depressive disorder (MDD) — commonly referred to as depression — affects approximately 20% of adults in the United States. MDD symptoms may include depressed mood, appetite changes, loss of pleasure, fatigue, difficulty concentrating, sleep changes, and suicidal thoughts. Despite the prevalence and dangerous symptoms associated with MDD, many patients are not effectively treated by standard medications. For those patients who may need additional treatment, the FDA approved VRAYLAR (cariprazine) as an adjunctive treatment for depression.

"Many living with major depressive disorder find that their ongoing antidepressant therapy doesn't offer meaningful relief from the symptoms they experience every day," said Thomas Hudson, MD, senior vice president of research and development, chief scientific officer, AbbVie, in the press release. "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."

VRAYLAR is administered as a once-daily oral antipsychotic. Its approval is based on the results of two studies: study 3111-303-001 and study RGH-MD-75. Study 311-303-001 was a randomized, double-blind, placebo-controlled clinical trial that randomized patients to receive 1.5 mg of cariprazine per day with antidepressant therapy (ADT), 3.0 mg of cariprazine per day with ADT, or a placebo and ADT. The study found a statistically significant improvement in the Montgomery—Åsberg Depression Rating Scale (MADRS) score for patients receiving 1.5 mg of cariprazine daily.

The RGH-MD-75 study recruited patients with an inadequate clinical response to a singular ADT treatment and assigned them to 1–2 mg of cariprazine per day, 2–4.5 mg of cariprazine per day, or a placebo. According to the press release, RGH-MD-75 showed an improved MADRS score within eight weeks for patients treated with 2–4.5 mg of cariprazine and ADT per day compared to the placebo and ADT group.

"Patients with inadequate response to standard antidepressant medication are often frustrated by the experience of trying multiple medicines and still suffering from unresolved symptoms. Instead of starting over with another standard antidepressant, VRAYLAR works with an existing treatment and can help build on the progress already made," said Gary Sachs, MD, clinical vice president at Signant Health, associate clinical professor of psychiatry at Massachusetts General Hospital, and lead Phase 3 clinical trial investigator, in the press release. "For adults living with major depressive disorder, because of inadequate improvement in response to standard antidepressants, VRAYLAR is an efficacious adjunctive treatment option with a well-characterized safety profile."