Indivior PLC has announced the U.S. launch of its once-monthly risperidone (Perseris) for extended-release injectable suspension. The once-monthly injection, administered subcutaneously, does not require patients to be taking additional oral risperidone.
Often, people with schizophrenia cannot perceive their illness, which can lead to their ceasing to take medication. Long-acting injectable antipsychotics give patients drug concentrations that stay within a therapeutic range for an extended period of time. The injection can help with treatment initiation and also eliminates the need for daily dosing of antipsychotic medications.
The FDA approval of Perseris, in July 2018, was based on a pivotal phase 3 study (NCT 02109562) in patients 18 to 55 years old with acute exacerbations of schizophrenia. Change in Positive and Negative Syndrome Scale (PANSS) total score at eight weeks was the primary efficacy endpoint. Both 90-mg and 120-mg doses showed a statistically significant improvement compared with placebo from baseline to end of study.
The most common systemic adverse reactions in the trial were increased weight, sedation/somnolence, and musculoskeletal pain. The most common injection-site reactions (≥ 5% of all patients across both groups) were injection-site pain and reddening of the skin.
Patients with a known hypersensitivity to risperidone, paliperidone, or other components of Perseris should not be given the drug. Risperidone is not approved for use in patients with dementia-related psychosis.
Source: Indivior PLC, February 28, 2019