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Shilpa Medicare's Breakthrough in Chemotherapy Treatment: OERIS™

Shilpa Medicare Limited has recently celebrated a significant milestone in its clinical research with the successful Phase 3 results for OERIS™, an innovative ondansetron injection designed for the effective management of chemotherapy-induced nausea and vomiting (CINV). The results promise to reshape patient care for hundreds of thousands undergoing chemotherapy.

Overview of the Phase 3 Study

The study, titled SMLINJ011, was a multicentric, randomized, double-blind trial that involved 240 participants across various oncology centers in India. The primary focus was to compare the efficacy of OERIS™ against conventional ondansetron injections, thereby emphasizing the former’s potential advantages in patient care.

Study Design and Objectives

• - Participants: 240 patients who had experienced CINV.
• - Primary Endpoint: The percentage of patients achieving a complete response (no vomiting episodes) within 120 hours post-chemotherapy.
• - Comparison: OERIS™ was compared with standard multiple-dose ondansetron injections.
• - Secondary Endpoints: Safety profile, delayed-phase response, and patient tolerability were also evaluated.

Key Findings

The outcomes of the Phase 3 trial were notable:

• - Complete Response Rate: OERIS™ demonstrated a complete response in 89% of patients, outpacing the 82% seen with traditional ondansetron.
• - Safety Profile: Importantly, the study reported no severe or serious adverse effects linked to the use of OERIS™, indicating a favorable safety profile comparable to standard treatments.

Transformative Potential of OERIS™

What distinguishes OERIS™ from traditional therapies is its extended antiemetic coverage through a single weekly injection. This innovative approach has the potential to prevent both acute and delayed CINV for up to five days after chemotherapy, thus minimizing the need for multiple daily doses or oral follow-ups.

This enhancement not only improves patient comfort but also streamlines clinical workflows, indicating a substantial shift toward more efficient healthcare delivery.

Leadership Perspectives

Vishnukant Bhutada, CEO of Shilpa Medicare Limited, expressed pride in the successful completion of the Phase 3 trial. He highlighted OERIS™ as a testament to Shilpa's dedication to blending scientific innovation with patient-centered care, reinforcing the company’s commitment to becoming a global leader in specialized pharmaceuticals.

Next Steps

With these promising results, Shilpa plans to submit a regulatory approval application to the Directorate General of Health Services (DCGI) in India. Furthermore, the company aims to pursue global registration and commercialization through the 505(b)(2) pathway in the United States and other key markets.

Importance of Addressing CINV

CINV remains a significant concern affecting 70-80% of chemotherapy patients, representing a market size of approximately $375 million. Poorly controlled nausea and vomiting can lead to treatment cessation and diminished quality of life, highlighting the critical need for long-acting treatments such as OERIS™.

About Shilpa Medicare

Shilpa Medicare is a leading Indian pharmaceutical company specializing in active pharmaceutical ingredients (APIs), formulations, and biologics within oncology and specialty fields. For further information, visit www.vbshilpa.com.

Conclusion

With OERIS™, Shilpa Medicare is not only advancing its portfolio in supportive oncology care but is also setting a new standard in managing chemotherapy side effects, significantly enhancing the quality of life for patients undergoing cancer treatment.