Luye Pharma Group announced the submission of a New Drug Application (NDA) for Rykindo (risperidone extended-release microsphere; LY03004) for Injectionto the Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar disorder.

Rykindo utilizes the Company’s long-acting and extended-release technology platform and is intended for intramuscular injection once every 2 weeks. Rykindo is thought to improve patient compliance by simplifying the regimen with an injection required only once every 2 weeks. In addition, Rykindo does not require administration of an oral formulation for 3 weeks after the first injection, compared with the currently available long-acting risperidone injection (reference drug).

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The NDA submission included data from 3 studies involving 172 patients. Data from 1 study showed no lag period with the first injection and an equivalent pharmacokinetic profile of Rykindo at steady state, compared with the reference drug. Compared with the reference product, safety profiles were comparable with Rykindo across all 3 studies.

If approved, the Company plans to launch Rykindo during the 2019-2020 period.

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