FDA Approves Risperidone for Adults With Schizophrenia

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The extended-release injectable suspension treatment represents the first subcutaneous, long-acting formulation of risperidone.

The US Food and Drug Administration (FDA) has approved risperidone (UZEDY) for the treatment of adult patients with schizophrenia.1

The extended-release injectable suspension treatment, developed by Teva Pharmaceuticals, represents the first subcutaneous, long-acting formulation of risperidone that used a copolymer technology called SteadyTeq to control the steady release of the drug. Therapeutic blood concentrations using this technology can be reached within 6-24 hours of a single dose of risperidone.

The approval is based on the results of a pair of phase 3 trials--TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia).

The RISE study was a multicenter, randomized, double-blind, placebo-controlled study where 544 patients were treated with the drug once monthly, once every 2 months, or placebo.

In the SHINE study, investigators evaluated the treatment for up to 56 weeks in 336 patients with schizophrenia.

Treatment adherence remains a large concern in schizophrenia, where approximately 80% of patients experience multiple relapses over the first 5 years of treatment. By utilizing the new technology with risperidone, investigators believe they can release the drug over time with no loading dose or oral supplementation.

A survey from 63 patients, 24 physicians, and 25 nurses show 89% of patients and 92% of healthcare providers deemed the treatment as easy to use, while 70% of patients said it provided a better injection experience than previous long-acting injectables and 90% said they would prefer to stick with risperidone.

“Treatments for schizophrenia are largely prescribed as daily oral medications, which can present challenges with adherence due to missed doses. Lack of adherence to treatment with oral antipsychotics is the most common cause of relapse in schizophrenia,6 so there’s a role for therapies that are dosed in one- or two-month dosing intervals to help prevent relapse,” said Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, in a statement.