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Indivior submits NDA to market RBP-7000 for schizophrenia
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Indivior recently submitted a New Drug Application to the FDA for marketing approval of RBP-7000, a once-monthly injectable risperidone in the Atrigel delivery system, for schizophrenia, according to a manufacturer-issued press release.
The submission included results from a phase 3 trial and an open-label, long-term safety study of RBP-7000.
Findings from the randomized, double-blind, placebo-controlled phase 3 study indicated greater improvements in Positive and Negative Syndrome Scale total and Clinical Global Impression-Severity scores at 8 weeks among participants who received RBP-7000 compared with placebo, according to the release.
Indivior also announced a definitive agreement with DURECT Corporation to purchase certain patent rights to further enhance the intellectual property position of RBP-7000. The purchase included U.S. Patent 9,597,402 and pending applications in the same family.
“The results from the pivotal phase 3 study assessing the efficacy of RBP-7000 demonstrated statistically significant improvement compared to placebo and was generally well-tolerated,” Christian Heidbreder, PhD, chief scientific officer of Indivior, told Healio.com/Psychiatry. “This program demonstrates our commitment to developing an innovative treatment option that may help overcome the challenges associated with this devastating disease.”