FDA Approves Extended-Release Risperidone for Schizophrenia

The FDA has approved Rykindo (risperidone) to treat adults with schizophrenia and as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. Developed by China-based company Luye Pharma Group, Rykindo is an extended-release injectable suspension administered via intramuscular injection once every two weeks. It was developed using Luye Pharma’s microsphere technology platform.

In the United States, there are about 24 million schizophrenia patients, and the estimated prevalence of schizophrenia and related psychotic disorders ranges between 0.25% and 0.64%. An estimated 4.4% of U.S. adults experience bipolar disorder at some point in their lives.

Rykindo has a black-box warning about use in elderly patients. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. It is not approved for use in patients with dementia-related psychosis.

Rykindo was approved for marketing in China in 2021 for the treatment of schizophrenia. The development in Europe is progressing, with plans to launch the drug in more countries and regions around the world.

According to the labeling, the effectiveness of Rykindo was established, in part, on the basis of the established effectiveness of the oral formulation of risperidone as well as in a 12-week, placebo-controlled trial in adult inpatients and outpatients. Efficacy data were obtained from 400 patients with schizophrenia who were randomized to receive injections of 25 mg, 50 mg, or 75 mg Rykindo or placebo every two weeks.

The primary endpoint was the Positive and Negative Syndrome Scale (PANSS), a widely used scale to assess antipsychotic therapies. Rykindo was associated with a significant improvement in the change from baseline to endpoint in schizophrenic patients.

The effectiveness for the maintenance treatment of bipolar I disorder is based on a placebo-controlled study of adult patients who with bipolar disorder type I, who were stable on medications or experiencing an acute manic or mixed episode. A total of 501 patients were enrolled. The primary endpoint was time to relapse to any mood episode. Time to relapse was delayed in patients receiving Rykindo monotherapy compared with patients receiving placebo. The majority of relapses were due to manic rather than depressive symptoms.

For the effectiveness for Rykindo as an adjunct to treatment to lithium or valproate for maintenance of bipolar 1 was based on a study of 240 patients. The primary endpoint was time to relapse to any new mood episode. Time to relapse was delayed in patients Rykindo compared with patients receiving adjunctive therapy with placebo. The relapse types were about half depressive and half manic or mixed episodes.

The most common adverse reactions in patients with schizophrenia were headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremity, and dry mouth. The most common adverse reactions in patients with bipolar disorder were weight increased and tremor and parkinsonism.