Indivior announced that Perseris (risperidone) for extended-release injectable suspension is now available in the United States. Perseris is approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults.
"The availability of Perseris provides physicians with a new treatment option to help address some of the challenges in treating schizophrenia," said Shaun Thaxter, Chief Executive Officer of Indivior. "We understand the complex patient journey of people living with schizophrenia and recognize the important role that long-acting injectables can play. Perseris is a demonstration of our ongoing commitment to developing innovative treatments for people living with this debilitating condition."
Perseris contains risperidone, a well-established medicine for schizophrenia, and uses an extended-release delivery system to form a subcutaneous (under the skin) depot that provides sustained levels of risperidone over one month. Clinically relevant levels were reached after the first injection of Perseris without use of a loading dose or any supplemental oral risperidone. Initial peak risperidone plasma levels occur within four to six hours of dosing and are due to an initial release of the drug during the depot formation process.
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The FDA approval of Perseris was based on a Phase 3 study assessing the efficacy, safety and tolerability of the product in patients aged 18 to 55 years with DSM-IV diagnosis of schizophrenia and an acute episode within eight weeks of screening for the study.
The Phase 3 study was a randomized, double-blind, placebo-controlled eight-week study of 354 patients. Perseris efficacy was demonstrated by a statistically significant improvement in the primary clinical endpoint, Positive and Negative Syndrome Scale (PANSS) total score at Day 57. The improvement in Clinical Global Impression Severity of Illness (CGI-S), the secondary endpoint, was also statistically significant at Day 57. Clinical trials of Perseris were designed for the product to be initiated with neither a loading dose nor any supplemental risperidone.
The safety of Perseris was evaluated in 814 adults with schizophrenia who received at least one dose of Perseris during clinical trials. A total of 322 patients were treated with Perseris for at least six months, with 234 of those treated with Perseris for at least 12 months. The systemic safety profile of Perseris was consistent with the known safety profile of oral risperidone. The most common systemic adverse reactions in the pivotal Phase 3 trial (in ≥5 percent of Perseris patients and greater than twice placebo) were increased weight, sedation/somnolence and musculoskeletal pain. The most common injection site reactions (≥5 percent of all patients across Perseris and placebo groups) were injection site pain and reddening of the skin.
"One of the biggest challenges physicians face when treating patients with schizophrenia is maintaining treatment over time, as the risk of relapse increases when treatment is interrupted," said Dr. John G. Csernansky Chair, Department of Psychiatry and Behavioral Sciences, Northwestern University. "The availability of Perseris provides physicians with a new risperidone LAI option that has important practical applications, such as subcutaneous administration, and oral supplementation or loading doses are not recommended."