India-based Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED) announced on Tuesday that it has completed its fourth complex clinical program SMLINJ011, with positive topline Phase three results for Shilpa's OERIS (Ondansetron Extended-Release Injection).

OERIS is an innovative formulation aimed at improving prophylaxis of chemotherapy-induced nausea and vomiting (CINV).

The company conducted a Phase III, multicentre, randomised, double-blind, non-inferiority trial across multiple oncology centres in India to compare OERIS with conventional ondansetron injections in 240 patients receiving moderately or highly emetogenic chemotherapy. It achieved a complete response rate of 89% in OERIS arm compared to 82% in standard ondansetron arm. There were no serious or severe adverse events reported. It is also claimed to have provided comparable or better tolerability than conventional therapy.

Shilpa says that it plans to file for regulatory approval with the DCGI and pursue global registration and commercialisation through the 505(b)(2) pathway in the US and other key markets.