Specialty pharmaceutical company Indivior has secured the US Food and Drug Administration (FDA) approval for the use of its Perseris (risperidone) to treat adults suffering from schizophrenia.
Perseris is said to be the first subcutaneous, once-monthly long-acting injectable (LAI) for risperidone, an existing medicine for schizophrenia.
The injection utilises an extended-release delivery system to form a subcutaneous depot that delivers sustained risperidone levels over one month.
Initial peak risperidone levels in plasma occur between four and six hours after dosing. These levels are said to be due to an initial drug release during the depot formation.
Indivior CEO Shaun Thaxter said: “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.”
The company investigated Perseris’ efficacy in a pivotal Phase III clinical trial performed in 354 subjects over a period of eight weeks.
Clinical studies for Perseris were designed to validate the initiation of the product without a loading dose or any supplemental risperidone.
Data from the randomised, double-blind, placebo-controlled trial revealed an improvement in the primary clinical endpoint of Positive and Negative Syndrome Scale (PANSS) total score at day 57.
It was additionally observed that the Clinical Global Impression Severity of Illness (CGI-S) improvement was statistically significant at day 57.
Perseris safety was assessed in a total of 814 patients administered with a minimum of one dose. Approximately 322 patients were given Perseris for at least six months, of which 234 participants received treatment for at least 12 months.
The systemic safety profile of the injectable was found to be consistent with the previously established profile of oral risperidone.