Treatment with RBP-7000 significantly reduced Positive and Negative Syndrome Scale (PANSS) total score and greatly increased the percentage of adults with schizophrenia achieving treatment response.
Indivior announced positive results from 2 phase 3 trials examining the efficacy, safety and tolerability of RBP-7000 (risperidone in ATRIGEL Delivery System), an investigational, subcutaneously administered, monthly extended-release depot formulation, in adults with schizophrenia.
In the 8-week double-blind study, treatment with RBP-7000 90 mg or 120 mg significantly reduced Positive and Negative Syndrome Scale (PANSS) total score and greatly increased the percentage of participants achieving treatment response versus placebo.
“These trials were designed not to require a loading dose or supplemental dosing,” Jay Graham, PharmD, medicines development leader, senior director, Indivior, told MD Magazine. “We are leveraging a known compound, with known efficacy, known safety profile in a different dosage form that’s administered monthly.”
In the double-blind study, 354 patients with a DSM-IV-TR diagnosis of schizophrenia were randomized to receive monthly injections of either placebo (n = 119), RBP-7000 90 mg (n = 116) or RBP-7000 120 mg (n = 119), and must have experienced an acute exacerbation of schizophrenia within 8 weeks of screening and been considered likely to benefit from psychiatric hospitalization, and were required to have a PANSS total score between 80—120 at screening, and a score >4 on at least 2 of the following items: hallucinatory behavior, delusions, conceptual disorganization or suspiciousness/persecution.
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