Promising schizophrenia drug faces tough competition

If approved, paliperidone palmitate extended-release injectable suspension (LY03010) is primed as a favourable option to treat schizophrenia, due to reduced dosage requirement of a once-a-month, yet it risks being hidden in a crowded long-acting injectable (LAI) market, GlobalData warns.

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna^® at steady state in a clinical trial (NCT04922593). GlobalData’s report showed LY03010 is expected to launch in the US in 2024. If successful, the drug is forecasted to reach sales of $63.5 million in 2031, representing 0.6 percent of the US schizophrenia market in 2031.

Like Invega Sustenna^®, LY03010 is administered intramuscularly once per month.  Prior to monthly injections, Invega Sustenna^® requires an initiation dosing regimen on day one and day eight. Comparatively, LY03010, the long-acting injectable does not require treatment to be given on day eight.

LY03010 clinical trial results as a treatment for schizophrenia

The randomised, multiple-dose, open-label, parallel-group study evaluated the pharmacokinetic profiles of LY03010 and the relative steady state bioavailability of LY03010 versus Invega Sustenna^® in patients with schizophrenia or schizoaffective disorder in 281 patients.

According to Luye Pharma, the study demonstrating the steady state bioavailability of LY03010 using the optimised initial dosing regimen compared with Invega Sustenna^® original initial dosing regimen, showed LY03010 gave desirable exposure levels within one week, equivalent to Invega Sustenna^®. LY03010 was well tolerated and showed no unexpected treatment-emergent adverse events (TEAEs) compared to Invega Sustenna^®. Thus, LY03010 could be more convenient to administer and improve patient compliance by optimising the initial dosing regimen, while ensuring efficacy and safety.

According to the pre-IND meeting with the US Food and Drug Administration (FDA), Luye Pharma plans to submit the New Drug Application (NDA) for LY03010 to the FDA through the 505(b)(2) pathway.

The long-acting injectable’s potential in the LAI market

Christie Wong, GlobalData Pharma Analyst commented: “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 (J&J) 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.”

GlobalData noted that key opinion leaders (KOLs) previously interviewed unanimously preferred to prescribe established LAIs over new pipeline products, especially if the pipeline agents are expected to have premium pricing.

Wong continued: “Although Luye Pharma currently markets Rykindo (risperidone ER) in China for the treatment of schizophrenia, the company is not well established in the schizophrenia market and may have trouble making in-roads with psychiatrists. Should LY03010 receive US Food and Drug Administration (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.”

Wong concluded: “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.”

GlobalData identified that a head-to-head study on how Luye Pharma’s LAI can improve treatment adherence and compliance, could help differentiate it from J&J’s paliperidone products.