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

Shilpa Medicare Announces Successful Phase 3 Results for OERIS™

Shilpa Medicare Limited (BSE: 530549) has reported significant breakthroughs in the fight against chemotherapy-induced nausea and vomiting (CINV) with its innovative product, OERIS™. This once-weekly ondansetron extended-release injection recently completed a Phase 3 clinical trial (SMLINJ011), yielding promising results that could change the landscape of supportive care in oncology.

Study Overview

Conducted across several oncology centers in India, the Phase 3, multicenter, randomized, double-blind, non-inferiority trial focused on 240 patients undergoing moderately to highly emetogenic chemotherapy. The main aim was to evaluate OERIS™ against conventional ondansetron injections, with primary and secondary endpoints set to measure efficacy, safety, and patient tolerability.

Key Study Parameters

• - Population: 240 patients diagnosed with CINV
• - Primary Endpoint: Complete response, defined as no emesis episodes in the 120 hours following chemotherapy
• - Comparator: Multiple doses of conventional ondansetron injection
• - Secondary Endpoints: Safety profile, delayed-phase response, and patient tolerability.

Results Highlights

The results revealed an impressive 89% complete response rate in the OERIS™ group, outperforming the 82% of patients receiving standard ondansetron treatment. Furthermore, the study reported no serious adverse effects associated with the OERIS™ injection, indicating its safety and better tolerability as compared to conventional therapies.

Transformative Approach

OERIS™ stands out due to its ability to provide extended antiemetic coverage through a single injection, which covers both acute and delayed phases of CINV for up to five days. This innovative design reduces the necessity for multiple daily doses or oral follow-ups, significantly enhancing patient adherence and streamlining clinical workflows.

Mr. Vishnukant Bhutada, Managing Director of Shilpa Medicare, commented, “The successful completion of this critical Phase 3 study reinforces Shilpa’s commitment to patient-centered innovation. OERIS™ is a prime example of how scientific advancements can translate into real-world solutions, enhancing our oncology-supportive care capabilities and supporting our mission to emerge as a leader in specialty pharmaceuticals.”

Future Directions

Following the successful trial results, Shilpa Medicare plans to submit an application for regulatory approval to the Drug Controller General of India (DCGI) and will pursue global registration and commercialization through the 505(b)(2) pathway in the United States and other key markets.

Understanding CINV

CINV represents a significant challenge in cancer treatment, affecting 70–80% of patients undergoing chemotherapy. The market for managing CINV is sizable, valued at approximately USD 375 million. Poorly controlled nausea can result in treatment abandonment and deteriorating quality of life, underscoring the critical need for long-acting therapies like OERIS™.

About Shilpa Medicare Limited

Shilpa Medicare is an esteemed Indian pharmaceutical company that specializes in APIs, formulations, and biologics, predominantly within oncology and specialty segments. With a commitment to innovation and excellence, Shilpa Medicare aims to meet the global demand for advanced healthcare solutions. For additional details, visit Shilpa Medicare's website.