Phase 3 data support Vraylar for bipolar I depression

Gary Sachs

Allergan and Gedeon Richter have announced phase 3 study results that demonstrate the efficacy of Vraylar for the treatment of adults with major depressive episodes associated with bipolar I disorder, according to a press release.

“As clinicians, it is our goal to improve the severity of the mood changes associated with bipolar disorder, which can cause significant personal distress, and can often have serious implications for a patient's health,” Gary Sachs, MD, associate clinical professor of psychiatry at Harvard Medical School, said in an interview. “However, bipolar disorder varies greatly from person to person, and so does the right medication. More treatment options are needed so that physicians can find a treatment that works best for each individual.”

In this phase 3, double-blind clinical trial, researchers evaluated the efficacy, safety and tolerability of Vraylar (cariprazine, Allergan) in 488 patients with bipolar I depression randomly assigned to receive cariprazine 1.5 mg per day, cariprazine 3 mg per day, or placebo.

The results showed that patients who received both 1.5-mg and 3-mg doses of cariprazine had significantly greater improvement compared with placebo at 6 weeks (P < .05), according to the release. Cariprazine was well-tolerated: 5% of patients treated with cariprazine discontinued due to adverse events compared with 2.5% of those treated with placebo, according to the release. The most common adverse events were sedation, somnolence, dizziness, akathisia and nausea.

This is the second positive pivotal trial that supports the use of cariprazine for this indication, according to the release. In the second half of 2018, Allergan plans to submit a supplemental New Drug Application to the FDA.

“Bipolar disorder is a common, complex, and often disabling condition in which abnormal mood states impair a person’s ability to carry out everyday tasks. During periods of illness, their symptoms impact family and friends, therefore bipolar disorder touches nearly every family and community in America,” Sachs told Healio Psychiatry. “These phase 3 data indicate that cariprazine could potentially be an effective new treatment for adults struggling to manage major depressive episodes associated with bipolar I disorder. With this trial, Allergan will have sufficient data to submit to the [FDA] so that cariprazine may be evaluated as a potential treatment option.” – by Savannah Demko

Disclosures: Sachs reports having a consulting agreement with Allergan under which his fees are donated to the Depression and Bipolar Support Alliance.