Rykindo Approved for Schizophrenia, Bipolar Disorder

The approval was based on data from adequate and well-controlled studies with risperidone long-acting injection (intramuscular).

The Food and Drug Administration (FDA) has approved Rykindo® (risperidone extended-release injectable suspension for intramuscular [IM] use) for the treatment of schizophrenia in adults, and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.

Rykindo, an atypical antipsychotic, is intended for intramuscular injection once every 2 weeks. The approval of Rykindo in the treatment of schizophrenia and bipolar I disorder was based on data from adequate and well-controlled studies with risperidone long-acting injection (IM).

Rykindo is supplied as a single-dose kit consisting of a vial, a prefilled syringe, clear diluent, a vial adapter, and a needle. It is available in 12.5mg, 25mg, 37.5mg, and 50mg dosage strengths. 

For patients who have never taken oral risperidone, prior to initiating Rykindo, tolerability with oral risperidone should be established.

References

  1. FDA approves Luye Pharma’s Rykindo® for the treatment of schizophrenia and bipolar 1 disorder. News release. Luye Pharma. January 15, 2023. Accessed January 17, 2023. https://www.prnewswire.com/news-releases/fda-approves-luye-pharmas-rykindo-for-the-treatment-of-schizophrenia-and-bipolar-1-disorder-301721891.html.
  2. Rykindo. Package insert. Luye Pharma; 2022. Accessed January 17, 2022. https://www.luye.cn/lvye_en/rykindo.pdf.