What's Happening?
Shilpa Medicare Limited has announced successful Phase 3 results for its OERIS™ (Ondansetron Extended-Release Injection), designed to treat chemotherapy-induced nausea and vomiting (CINV). The study, conducted
across multiple oncology centers in India, demonstrated superior convenience, efficacy, and safety compared to conventional ondansetron injections. The trial involved 240 patients and met all primary and secondary endpoints, with a complete response rate of 89% in the OERIS™ arm versus 82% in the standard arm. The injection offers extended antiemetic coverage for up to five days, enhancing patient convenience and compliance.
Why It's Important?
The development of OERIS™ represents a significant advancement in oncology supportive care, addressing a critical need for effective long-acting therapies for CINV. Poorly controlled CINV can lead to treatment discontinuation and reduced quality of life for patients undergoing chemotherapy. By providing a once-weekly injection, OERIS™ simplifies treatment regimens and improves patient outcomes. This innovation strengthens Shilpa Medicare's position in the pharmaceutical industry, particularly in the oncology segment, and highlights the company's commitment to patient-centric solutions.
What's Next?
Shilpa Medicare plans to seek regulatory approval from the DCGI and pursue global registration and commercialization through the 505(b)(2) pathway in the US and other key markets. The company aims to expand its oncology-supportive-care portfolio and establish itself as a global leader in specialty pharmaceuticals. The market for CINV therapies is substantial, with a projected value of USD 375 million, indicating significant growth potential for OERIS™.
