Indivior Launches Extended-Release Injectable Suspension for Schizophrenia
Approved by the FDA in July 2018, Perseris is the first once-monthly, subcutaneous risperidone-containing, long-acting injectable available in the United States.
Indivior’s once-monthly schizophrenia treatment risperidone (Perseris) extended-release injectable suspension has launched in the United States, the company announced in a press release.
Risperidone, which was approved by the FDA in July 2018, is the first once-monthly, subcutaneous risperidone-containing, long-acting injectable available in the United States.
The therapy uses an extended-release delivery system to form a depot under the skin following abdominal subcutaneous administration by a health care provider. Initial peak risperidone plasma levels occur within 4 to 6 hours of dosing and are due to an initial release of the drug during the depot formulation process, according to Indivior. Additionally, providers should establish tolerability with oral risperidone first before starting patients on the new therapy.
Risperidone’s approval was based on data from a phase 3 trial evaluating the efficacy and safety of risperidone. In an 8-week study of 354 patients, efficacy was demonstrated by an improvement in the primary clinical endpoint, Positive and Negative Syndrome Scale total score at day 57. There was also a statistically significant improvement in Clinical Global Impression Severity of Illness at day 57. Clinically relevant levels were reached after the first injection without use of a loading dose or any supplemental oral risperidone, according to the study.
In the trial, the most common adverse reactions were increased weight, sedation/somnolence, and musculoskeletal pain.
Because schizophrenia is a complex disease that requires ongoing treatment, adherence is often a challenge for many patients. The once-monthly, subcutaneous treatment offers patients an additional therapeutic option that could eliminate the need for daily dosing.
“Schizophrenia is a complex disease and part of the complexity is that a patient may not recognize that they are ill and therefore not see the need to take medicine,” Anne Andorn, MD, chief medical officer at Indivior, said in a statement. “Perseris is a once-monthly injection of a commonly prescribed medication known to reduce symptoms of schizophrenia and does not depend on the patient taking additional oral medication. Reducing the symptoms of schizophrenia is a very important to help reduce the abnormal behavior that can lead to the stigma of the disease.”
Patients on stable doses of oral risperidone lower than 3 mg or higher than 4 mg per day may not be candidates for risperidone, according to Indivior.
Indivior Announces Launch of PERSERISTM (risperidone) for the Treatment of Schizophrenia in Adults [news release]. Indivior. http://indiviormedia.com/#restoftext. Accessed February 27, 2019.