FDA Approves Bi-Weekly Extended-Release Risperidone for Schizophrenia and Bipolar I

The US Food and Drug Administration (FDA) approved Rykindo® (risperidone), an extended-release injectable suspension to treat schizophrenia in adult patients, maker Luye Pharma Group (Luye Pharma) announced Monday. The drug is approved as a monotherapy adult schizophrenia treatment or as an adjunctive therapy to lithium or valproate for the maintenance treatment of adult bipolar I treatment.

"Rykindo® is our first new drug developed in-house and approved for marketing in the US, demonstrating our long-standing commitment to serving patients around the world with innovative therapies," said Yang Rongbing, President of Luye Pharma Group.

Through long-acting extended-release microsphere technology, the bi-weekly drug is administered via intramuscular injection and delivers the active ingredient, risperidone.

>>RELATED FDA Accepts NDA for Twice Monthly LAI for Schizophrenia and Bipolar I Treatment

The following 3 clinical trials demonstrated the treatment’s efficacy: 

1. First, an open-label, single-ascending dose pharmacokinetic and safety study in patients with schizophrenia or schizoaffective disorder following escalating single intramuscular injection;
2. Next, a randomized, open-label, parallel-group study assessed the relative bioavailability of LY03004 (Rykindo®) and Risperdal® Consta® at 25 mg following multiple intramuscular injections in stable patients with schizophrenia or schizoaffective disorder; and
3. Finally, in a randomized open-label pharmacokinetic study of LY03004 that compared Risperdal® Consta® following a single intramuscular injection at 25-mg or 50-mg in stable patients with schizophrenia and/or schizoaffective disorder.

The most common adverse reactions in patients with schizophrenia (≥ 5%) were headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth.

The most common adverse reactions in patients with bipolar disorder were (5% in monotherapy trial) increased weight increase, and tremor and parkinsonism (≥ 10% in adjunctive therapy trial).

Rykindo® is not FDA approved for use in patients with dementia-related psychosis. The drug comes with a black box warning stating elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death.

The drug is contraindicated for patients with known hypersensitivity to risperidone, paliperidone, or any components of Rykindo®.
In 2021, Rykindo® was approved for marketing in China as a schizophrenia treatment and is still progressing in Europe. Luye Pharma plans to launch the drug in more countries around the world, according to a news release.

Reference

FDA approves Luye Pharma’s Rykindo® for the treatment of schizophrenia and bipolar I disorder. News release. Luye Pharma. January 15, 2023. Accessed January 16, 2023.