Indivior announced that the Food and Drug Administration (FDA) has approved Perseris, a once-monthly subcutaneous (SC) risperidone-containing, long-acting injectable for the treatment of schizophrenia in adults.

Perseris, an atypical antipsychotic, has an extended-release delivery system that releases sustained levels of risperidone over 1 month. Data showed clinically relevant levels of risperidone were achieved after the first injection without a loading dose or any supplemental oral risperidone doses. 

Perseris was evaluated in a Phase 3, randomized, double-blind, placebo-controlled, 8-week study in adult patients experiencing acute exacerbations of schizophrenia (N=354). Its efficacy was demonstrated by an improvement in the Positive and Negative Syndrome Scale (PANSS) total score at day 57 (primary endpoint). Also, treatment with Perseris showed a statistically significant improvement in Clinical Global Impression Severity of Illness (CGI-S) at day 57. 

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The systemic safety profile of Perseris was consistent with the established safety of oral risperidone, according to data from 814 adults with schizophrenia who received ≥1 dose during the trials. Weight gain, sedation, somnolence, and musculoskeletal pain were the most common systemic adverse effects reported; injection site reactions such as pain and reddening of the skin were also commonly reported. Perseris carries a Boxed Warning indicating an increased risk of mortality in elderly patients with dementia-related psychosis; it is not approved for use in these patients. 

Perseris is available in strengths of 90mg and 120mg and is supplied in single-dose kits containing the risperidone powder, delivery system, and safety needle.

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