The U.S. Food and Drug Administration (FDA) approved Indivior’s Perseris for schizophrenia.
The U.S. Food and Drug Administration (FDA) approved Indivior’s Perseris for schizophrenia.
Perseris is the first once-monthly subcutaneous risperidone-containing, long-acting injectable for schizophrenia in adults. Risperidone is a common drug used to treat schizophrenia. Perseris utilizes an extended-release delivery system using an under-the-skin method of delivery that provides sustained levels of the drug over a month. Initial peak levels happen within the first four to six hours of dosing.
“Treatment adherence is a major challenge in schizophrenia due to the complexity of the disease,” said Maurizo Fava, executive vice chair of the Massachusetts General Hospital Department of Psychiatry and Indivior clinical research consultant, in a statement. “It is important to have additional treatment options available to physicians to help them improve their patients’ symptom severity. The studies carried out by Indivior suggest that Perseris may offer patients, caregivers and physicians a new once-monthly subcutaneous medication options to treat adults with schizophrenia.”
The submission to the FDA included results from its Phase III randomized, double-blind, placebo-controlled, 8-week trial of 354 patients. The drug showed an improvement in its primary clinical endpoint, Positive and Negative Syndrome Scale (PANSS) total score at day 57. Also, the improvement in Clinical Global Impression Severity of Illness (CGI-S) showed statistical significance at day 57.
It was also evaluated for safety in 814 adults with schizophrenia who took at least one dose of Perseris during the trial. A total of 322 patients received Perseris for at least six months, and 234 received it for at least 12 months. The safety profile of Perseris was consistent with that of oral risperidone.
The most common side effects were weight gain, sedation/somnolence and musculoskeletal pain.
The company, which is listed in the U.K., said it plans to review the launch timing for Perseris, which it will announce no later than November 1. MarketWatch notes, “The review of the launch follows a decision by the U.S. Court of Appeals for the Federal Circuit to expedite an appeal against a ruling that protected another of Indivior’s drugs, the opioid-addiction treatment Suboxone.”
MarketWatch continues, “A preliminary injunction prohibited rival pharmaceutical company Dr. Reddy’s Laboratories Ltd. from using, importing, selling or offering to sell its generic version of Indivior’s drug, Indivior said. Dr. Reddy’s appealed the ruling and filed emergency motions seeking to expedite the appeal of the preliminary injunction and to stay the ruling pending a decision on the appeal.”
At this point, the Court of Appeals hasn’t ruled on Dr. Reddy’s motion. Oral arguments are likely to be held in the first week of October.
Of today’s approval, Shaun Thaxter, Indivior’s chief executive officer, stated, “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. People with schizophrenia face a complex patient journey that can be hindered by ignorance, apathy and stigma. Indivior is committed to working with stakeholders to reduce the stigma of schizophrenia and expand access to evidence-based treatment.”
