AbbVie seeks added indication for blockbuster antipsychotic

Feb. 24, 2022

AbbVie is aiming to add another approved use for its antipsychotic drug cariprazine. The North Chicago-based company has submitted a supplemental new drug application to the U.S. FDA for the use of cariprazine as an add-on treatment for patients with major depressive disorder.

Results from late-stage clinical trials showed that cariprazine, sold under the name Vraylar in the U.S., reduced depressive symptoms when added to patients’ ongoing antidepressant treatment, said Michael Severine, president and vice chairman of AbbVie. Both trials found the drug to be safe, with no new safety events occurring, according to AbbVie.

A phase 3 study, called study 311-301-001, split 759 patients from seven countries into groups to monitor the effects of the drug on patients’ depressive symptoms over six weeks. The follow-up registration study, called RGH-MD-76, which was conducted to confirm the safety and efficacy of the drug, involved 808 participants from six countries over eight weeks. Both studies showed a statistically significant change in depressive symptoms from the baseline to conclusions of the trials.

Preliminary study findings announced back in October reported mixed results. In a second phase 3 clinical trial, Study 3111-302-001, cariprazine failed to achieve statistical significance over placebo in reducing depressive symptoms from baseline to week six. However, the positive results of study 3111-301-001 and RGH-MD-75 appeared to be enough for AbbVie to move forward with the sNDA.

“This submission demonstrates our strong commitment to addressing additional gaps in the care of people affected by psychiatric disorders,” said Michael Severino, president and vice chairman of AbbVie.

As of 2020, an estimated 21 million adults had at least one major depressive episode.  According to the World Health Organization, depression is the third-leading cause of disability worldwide. In the U.S., MDD has an estimated economic burden of $326 billion.

In September 2015, Vraylar was approved by the FDA for treatment of manic or mixed episodes associated with bipolar I disorder or schizophrenia. In May 2019, approval was expanded to treat depressive episodes of bipolar I disorder in adults.

AbbVie is also currently conducting phase 1 trials testing the use of Vraylar for the treatment of Autism Spectrum Disorder.