#India #Shilpa Medicare #Raichur #OERIS™ #CINV

Shilpa Medicare’s Innovative OERIS™: A Breakthrough in Chemotherapy-Induced Nausea Treatment

Shilpa Medicare Limited has recently made waves in the pharmaceutical industry with the successful completion of a Phase III clinical trial for OERIS™ (Ondansetron Extended-Release Injection). This innovative product is designed to address the significant issue of chemotherapy-induced nausea and vomiting (CINV). With its single weekly injection, OERIS™ offers a promising alternative to traditional treatment regimens, enhancing both efficacy and patient experience.

Overview of the Study

The Phase III trial, named SMLINJ011, involved a multicenter, randomized, double-blind design focusing on 240 patients undergoing moderately to highly emetogenic chemotherapy. The study aimed to compare the overall effectiveness of OERIS™ with standard ondansetron injections. Notably, the primary endpoint, which measured complete response (defined as no vomiting episodes within 120 hours post-chemotherapy), was successfully reached.

Key Findings from the Trial

• - Complete Response Rates: The trial data revealed an impressive 89% complete response rate in the OERIS™ group, compared to 82% in the conventional treatment group.
• - Safety Profile and Tolerability: Analyzing the safety parameters showed that no serious adverse events were reported, affirming the favorable tolerability of OERIS™ compared to traditional therapy methods.
• - Patient Comfort and Compliance: Significantly, OERIS™ eliminates the need for multiple daily doses, thereby enhancing patient adherence and overall comfort in managing CINV.

A Transformative Treatment Option

OERIS™ represents a substantial advancement in providing antiemetic care, as it protects against both acute and delayed CINV for up to five days with a single injection. This groundbreaking innovation not only simplifies the treatment process for healthcare professionals but also alleviates the burden on patients who are often overwhelmed by multiple medications during their chemotherapy treatment. This feature is particularly noteworthy since CINV detracts from the quality of life for up to 70–80% of chemotherapy patients.

Future Directions for Shilpa Medicare

Following the triumph of the Phase III study, the company plans to submit a regulatory filing to the Drug Controller General of India (DCGI) and intends to pursue global registration and marketing strategies. The potential path of 505(b)(2) FDA filing to enter the U.S. market and other key regions marks a pivotal step toward making OERIS™ accessible to a broader patient population.

Conclusion

Shilpa Medicare's commitment to innovation in the oncology sector is clearly reflected in the development of OERIS™. The product is not just a testament to pharmaceutical advancements but also shines a light on the company’s dedication to improving patient-centered care in oncology. According to Mr. Vishnukant Bhutada, Managing Director of Shilpa Medicare Limited, the successful trial completion underscores the company’s mission to merge scientific innovation with patient-oriented design, increasingly positioning itself as a leader in specialty pharmaceuticals globally. As the company continues to pave the way forward, OERIS™ stands to revolutionize how CINV is managed and treated, ultimately benefiting countless patients undergoing chemotherapy worldwide.