Shilpa Medicare Ltd has announced successful Phase-III results for OERIS™, a once-weekly extended-release Ondansetron injection developed to prevent chemotherapy-induced nausea and vomiting (CINV). The trial met all primary and secondary endpoints, demonstrating superior efficacy, safety, and patient convenience compared to conventional treatments.
Shilpa Medicare Ltd has achieved a major milestone in oncology supportive care with the completion of its fourth complex clinical program (SMLINJ011), yielding positive Phase-III results for OERIS™. This novel formulation of Ondansetron is designed for once-weekly administration, offering a more convenient and effective solution for managing chemotherapy-induced nausea and vomiting (CINV).
Key Highlights:
- Trial conducted as a multicenter, randomized, double-blind, non-inferiority study across leading oncology centers in India
- Enrolled 240 patients undergoing moderately or highly emetogenic chemotherapy regimens
- OERIS™ achieved an 89% complete response rate, outperforming the 82% rate seen in the conventional Ondansetron group
- No serious or severe adverse events were reported, affirming the safety profile of the drug
- Once-weekly dosing improves patient compliance and reduces treatment burden
- Reinforces Shilpa Medicare’s commitment to differentiated drug delivery and innovation in oncology care
This development positions Shilpa Medicare as a frontrunner in patient-centric cancer therapeutics, with OERIS™ poised to enhance global standards in supportive oncology treatment.
Sources: The Hindu, FinanzNachrichten, WebIndia123, FT Markets, PTI News, The Hindu Business Line.