Clinical Edge

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FDA Approves Perseris for Schizophrenia

FDA news release; 2018 Jul 27

Indivior PLC has announced that the US Food and Drug Administration (FDA) has approved Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults. Clinically relevant levels were reached after the first injection of Perseris without use of a loading dose or any supplemental oral risperidone. Indivior PLC is headquartered in Slough, England, and Richmond, VA.

Indications: Perseris contains risperidone, a well-established treatment for schizophrenia, and uses the extended-release delivery system to form a subcutaneous (under the skin) depot that provides sustained levels of risperidone over 1 month. 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 formation process.

Dosage/administration: Perseris may be initiated at a dose of 90 mg or 120 mg. It should be administered monthly by subcutaneous injection in the abdomen by a healthcare professional. No >1 dose should be administered per month.

Adverse reactions: The most common adverse reactions in clinical trials (≥5% and >twice placebo) were increased weight, sedation/somnolence, and musculoskeletal pain.

Citation:

FDA approves Perseris (risperidone) for extended-release injectable suspension for the treatment of schizophrenia in adults. [news release]. Slough, England, and Richmond, VA: Indivior PLC. July 27, 2018. https://www.prnewswire.com/news-releases/fda-approves-perseris-risperidone-for-extended-release-injectable-suspension-for-the-treatment-of-schizophrenia-in-adults-300688082.html. Accessed August 7, 2018.

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