Posted from: Monday, September 17, 2018 - 11:54 AM - Present

Perseris Approved to Treat Schizophrenia

July 27, 2018 – The U.S. FDA has approved Perseris™ (risperidone), manufactured by Indivior, to treat adult patients who have schizophrenia. It is the first once-monthly, long acting subcutaneous injectable form of risperidone.

Risperidone, was first approved for use in the United States in 1993 and is available in several dosage forms, including oral tablets, oral solution, and for injection. Perseris, once injected, creates a depot under the skin that releases risperidone at sustained levels. Recommended dosing is one 90mg or 120mg injection administered once a month by a healthcare professional. A loading dose or supplemental administration of oral risperidone are not recommended.

By contrast, Janssen’s Risperdal Contra® (risperidone) long-acting injection must be given via deep intramuscular (IM) injection once every two weeks at a dose of 25mg, 37.5mg, or 50mg. Patients should receive oral risperidone with the first Risperdal Contra injection, and continue with oral risperidone for three weeks to maintain appropriate concentrations of medication in the body.

With both Perseris and Risperdal Contra, patients should try oral risperidone first to determine their body’s ability to tolerate the drug before switching to a long-acting injectable form.

All risperidone products carry a black box warning that indicates they should not be used to treat elderly patients who have dementia-related psychosis. These patients have an increased risk of death when treated with antipsychotic medications like risperidone.

Indivior has launched Perseris at an average wholesale price of $2,052 for a 90mg syringe and $2,736 for a 120mg syringe.

Last Updated Friday, October 19, 2018 - 01:28 AM.