Industry Briefs

FDA Rejects Request to Consider Cariprazine for Treating Negative Symptoms

The FDA has refused Allergan’s request to review a Supplemental New Drug Application (sNDA) to expand the approved uses of the antipsychotic Vraylar (cariprazine) to include negative symptoms of schizophrenia. Currently, Vraylar is indicated for the general treatment of schizophrenia as well as the acute treatment of manic or mixed episodes in adults with bipolar I disorder.

Upon its preliminary review, the FDA determined that Allergan’s sNDA for treatment of negative symptoms was not sufficiently complete to permit a substantive review.

“We are disappointed with the FDA decision on our submission,” Allergan Chief Research and Development Officer David Nicholson, Ph.D., said in a press release. “We remain committed to our mental health program and to cariprazine and its potential as a treatment option for patients suffering from negative symptoms associated with schizophrenia.”

Indivior Submits NDA for Long-Acting Injectable Risperidone Formulation

Indivior Inc. has submitted a New Drug Application (NDA) to the FDA for its investigational compound RBP-7000, a once-monthly injectable formulation of risperidone that uses Indivior’s Atrigel delivery system. Atrigel is a biodegradable polymer that enables the controlled release of drugs in the bloodstream.

The NDA submission includes the results from both a randomized, placebo-controlled phase 3 study of inpatients with an acute exacerbation of schizophrenia and an open-label, long-term safety study. Patients taking RBP-7000 during the eight-week phase 3 study demonstrated statistically significant improvements in both the Positive and Negative Syndrome Scale (PANSS) scores and Clinical Global Impression-Severity of Illness (CGI-S) scores compared with placebo. ■