China-based Luye Pharma Group (HKG: 2186) has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its product, paliperidone palmitate extended-release injectable suspension (LY03010), via the 505(b)(2) regulatory pathway. The drug is under consideration for approval as a treatment for schizophrenia and schizophrenic affective disorder.
Clinical Trial Results and Bioequivalence
The filing is supported by a randomized, multi-dosed, open-label, INVEGA SUSTENNA parallel controlled pivotal study. The results have demonstrated that LY03010 exhibits bioequivalence with the control drug INVEGA SUSTENNA when administered multiple times to achieve steady state. Furthermore, LY03010 has the potential to reduce the frequency of initial administration compared to INVEGA SUSTENNA, eliminating the need for medication on the eighth day post-first injection while maintaining comparable exposure levels and a favorable safety and tolerability profile.
Benefits of Paliperidone Palmitate
Paliperidone palmitate is a second-generation antipsychotic drug available in oral and long-acting injection forms. It is effective in alleviating positive psychiatric symptoms and improving cognitive and emotional symptoms associated with schizophrenia. The long-acting injection form offers the advantage of less frequent administration compared to oral formulations, sustaining stable effective blood drug concentrations over the long term. This can enhance patient compliance and significantly reduce the risk of recurrence.
Global Regulatory Progress
The drug is also awaiting a regulatory decision in China and received clinical trial approval in Europe in February 2023, indicating Luye Pharma’s commitment to expanding access to this treatment globally.
Conclusion
Luye Pharma’s filing of the NDA for LY03010 with the US FDA is a significant step towards providing an alternative treatment option for schizophrenia patients. If approved, LY03010 could offer a more convenient and potentially more effective treatment regimen, improving outcomes and quality of life for individuals living with this mental health condition.-Fineline Info & Tech
