Positive results for Luye Pharma schizophrenia drug

LY03010 faces a crowded market, says GlobalData

LY03010 is anticipated to be launched in the US in Q2 2024. (Unsplash)

Luye Pharma’s pipeline asset LY03010, a once-monthly, long-acting injectable (LAI) form of paliperidone, has achieved the primary endpoint in a pivotal trial and demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna at steady state. If approved, it will create more options for the management of schizophrenia, but will have to face a crowded LAI market, says GlobalData, a leading data and analytics company.

According to GlobalData’s report – “Schizophrenia Market Size and Trend Report including Epidemiology and Pipeline Analysis, Competitor Assessment, Unmet Needs, Clinical Trial Strategies and Forecast, 2021-2031”— LY03010 is anticipated to be launched in the US in Q2 2024. It is forecast to reach sales of $63.5 million in 2031, representing 0.6% of the US schizophrenia market in 2031.

Christie Wong, Pharma analyst at GlobalData, said: “Although a useful addition to the schizophrenia treatment arsenal, the uptake of LY03010 is anticipated to be limited as the market is crowded with LAIs that are reformulations of popular antipsychotics such as aripiprazole, risperidone and paliperidone. In particular, Johnson and Johnson is a major player with four paliperidone products having a wide range of dosing frequencies, including a daily oral tablet and injectables administered monthly, quarterly, or biannually.”

Like Invega Sustenna, LY03010 is administered intramuscularly once a month.  Prior to monthly injections, Invega Sustenna requires an initiation dosing regimen where patients receive treatment on day one and day eight. In contrast, LY03010 optimizes the initial dosing protocol such that treatment on day eight is not required. 

Wong added: “As LAIs must be administered by a healthcare profession, the optimized initial dose offered by LY03010 could be more convenient to physicians and patients.”

However, key opinion leaders (KOLs) previously interviewed by GlobalData were unanimous in their preference to prescribe established LAIs over the new pipeline products, especially if the pipeline agents are anticipated to have premium pricing.

Wong said: “Although Luye Pharma currently markets Rykindo (risperidone ER) in China for the treatment of schizophrenia, the company is not very well established in the schizophrenia market and may have trouble making in-roads with psychiatrists. Should LY03010 receive FDA approval, Luye Pharma will need to provide solid marketing and competitive pricing to set it apart from competitors and convince payers to reimburse it.”

A completion of a head-to-head study by Luye Pharma investigating an improvement in treatment adherence and compliance through the LY03010 dosing regimen will help differentiate it from Johnson and Johnson’s portfolio of paliperidone products.

“Over the past decade, one continuing trend in the schizophrenia R&D space is the development of antipsychotic reformulations to improve treatment adherence. Switching from a daily oral therapy to a once-monthly LAI, such as LY03010, can improve patient compliance and reduce the risk of relapse due to inadequate management of maintenance treatment,” Wong concluded.



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