Shilpa Medicare's Extended-Release Ondansetron Injection Shows Superior Efficacy in Phase 3 CINV Trial
Key Insights
Shilpa Medicare's OERIS (search)™ demonstrated 89% complete response rate versus 82% for conventional ondansetron in preventing chemotherapy-induced nausea and vomiting.
The Phase 3 trial enrolled 240 patients and met all primary and secondary endpoints with no serious adverse events reported.
The extended-release formulation provides up to five days of antiemetic coverage from a single injection, eliminating multiple daily doses.
Shilpa Medicare Limited has announced positive topline results from its Phase 3 clinical trial evaluating OERIS (search)™ (Ondansetron Extended-Release Injection), a novel formulation designed to prevent chemotherapy-induced nausea and vomiting (CINV). The multicenter, randomized, double-blind, non-inferiority trial demonstrated superior efficacy compared to conventional ondansetron injections while maintaining an excellent safety profile.
Phase 3 Trial Results
The study enrolled 240 patients receiving moderately or highly emetogenic chemotherapy across multiple oncology centers in India. OERIS (search)™ achieved an 89% complete response rate compared to 82% for standard ondansetron injections, with complete response defined as no emesis episodes through 120 hours post-chemotherapy.
The trial met all primary and secondary endpoints, with no serious or severe adverse events reported in the OERIS (search)™ treatment arm. Safety and tolerability were comparable or better than conventional therapy, according to the study results.
Extended-Release Innovation
OERIS (search)™ represents a significant advancement in CINV management through its extended antiemetic coverage. The formulation provides effective prevention of both acute and delayed CINV for up to five days through a single injection, eliminating the need for multiple daily doses or oral follow-up medications.
"We are proud to announce the successful completion of this pivotal Phase 3 study," said Vishnukant Bhutada, Managing Director of Shilpa Medicare Limited. "OERIS (search)™ exemplifies Shilpa's ability to combine scientific innovation with patient-centric design, strengthening our oncology-supportive-care portfolio and our vision to become a global leader in specialty pharmaceuticals."
Market Impact and Regulatory Path
CINV affects up to 70-80% of patients undergoing chemotherapy and represents a market of approximately USD 375 million. Poorly controlled CINV can lead to treatment discontinuation and reduced quality of life, highlighting the clinical need for long-acting therapies like OERIS (search)™.
Shilpa Medicare plans to file for regulatory approval with India's Drug Controller General (DCGI) and pursue global registration and commercialization through the 505(b)(2) pathway in the United States and other key markets. This regulatory pathway allows for expedited approval of modified versions of previously approved drugs.
Company Portfolio Expansion
The successful completion of clinical program SMLINJ011 marks Shilpa's fourth complex clinical program and underscores the company's growing leadership in differentiated drug-delivery systems and oncology supportive-care therapeutics. Shilpa Medicare specializes in APIs, formulations, and biologics across oncology and specialty segments.