FDA accepts NDA for RBP-7000 to treat schizophrenia

Christian Heidbreder

The FDA has accepted the New Drug Application for Indivior’s RBP-7000, a once-monthly, sustained release, injectable risperidone in the Atrigel delivery system, for the treatment of schizophrenia, according to a press release.

This NDA submission is based on the results from a phase 3, randomized, placebo-controlled study that examined the efficacy and safety of RBP-7000, and an open-label, long-term safety study, according to the release. In the phase 3 study, RBP-7000 showed statistically significant clinical improvement compared with placebo at 8 weeks based on changes in mean Positive and Negative Syndrome Scale total and Clinical Global Impression-Severity of Illness scores, according to the release. The FDA has set the Prescription Drug User Fee Act target action date for July 28, 2018.

“FDA acceptance of our RBP-7000 NDA is a significant milestone for Indivior as we expand our treatment portfolio to offer a meaningful therapeutic option to help address noncompliance with medication administration in the treatment of schizophrenia,” Christian Heidbreder, PhD, chief scientific officer at Indivior, said in the release. “We look forward to closely working with the Agency during the review process to support the approval of RBP-7000 and to provide both physicians and patients this innovative treatment option.”

Disclosures: Heidbreder is an employee of Indivior.