Extended-Release Injection for Schizophrenia Receives FDA Approval

The long-acting injectable risperidone (Perseris) will provide an alternative to daily oral medication to improve treatment adherence for patients with schizophrenia.

The US Food and Drug Administration (FDA) has approved Perseris, a long-acting injectable suspension containing risperidone, for the treatment of adults with schizophrenia. Perseris is a once-monthly treatment, delivered subcutaneously that provides sustained levels of risperidone over the course of 1 month.

"Treatment adherence is a major challenge in schizophrenia due to the complexity of the disease. It is important to have additional treatment options available to physicians to help them improve their patients' symptom severity," said Maurizio Fava, MD, Executive Vice Chair of the Massachusetts General Hospital (MGH) Department of Psychiatry and Indivior clinical research consultant.

The approval decision was supported by data from a phase 3 randomized, double-blind, and placebo-controlled study. The 259 patients with acute schizophrenia included in the 8-week study received 2 subcutaneous doses of the risperidone injection.

The study demonstrated efficacy as measured by an improvement in Positive and Negative Syndrome Scale (PANSS) total score at day 57. The study additionally reported significant improvement in Clinical Global Impression Severity of Illness (CGI-S) at day 57.

"The studies carried out by Indivior suggest that Perseris may offer patients, caregivers and physicians a new once-monthly subcutaneous medication option to treat adults with schizophrenia," said Fava.

A previous study of long-acting, injectable risperidone evaluated the safety of the drug in 814 adults with schizophrenia. Each participant received at least 1 dose, 322 patients were treated with risperidone injections for at least 6 months, and 234 were treated for at least 12 months. The safety profile is consistent with the known safety profile for oral risperidone.

"Schizophrenia is a devastating, chronic and often disabling mental health condition that impacts the lives of people suffering from this illness, their families and caregivers. The approval of Perseris brings us the opportunity to provide adult patients and their healthcare providers with an innovative treatment option that we believe will make a meaningful difference," said Shaun Thaxter, Chief Executive Officer of Indivior.

The most common adverse effects noted in clinical trials, occurring ≥5% and greater than twice the rate of placebo, were increase weight, sedation, somnolence, and musculoskeletal pain. Common injection site reactions (≥5%) were injection site pain and erythema.

Other adverse reactions listed in the boxed warning include tardive dyskinesia, metabolic changes, hyperprolactinemia, orthostatic hypotension, falls, seizures, dysphagia, and priapism.

"People with schizophrenia face a complex patient journey that can be hindered by ignorance, apathy and stigma,” added Thaxter. “Indivior is committed to working with stakeholders to reduce the stigma of schizophrenia and expand access to evidence-based treatment."