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

Shilpa Medicare's Promising Advances with OERIS™

Shilpa Medicare Limited has announced exciting developments regarding its newest product, OERIS™, a once-weekly ondansetron extended-release injection. The company reported successful outcomes from its Phase 3 clinical trial, marked as SMLINJ011, which focused on addressing chemotherapy-induced nausea and vomiting (CINV)—a significant issue for cancer patients undergoing treatment.

Overview of the Clinical Trial

Conducted across multiple oncology centers in India, this Phase 3 study involved 240 participants undergoing moderately or highly emetogenic chemotherapy. The key aim was to compare the effectiveness of OERIS™ with that of conventional ondansetron injections. The design of the trial ensured a randomized, double-blind, non-inferiority framework to yield reliable results.

Key Findings

The study successfully met all primary and secondary endpoints. Notable highlights include:

• - Complete Response Rates: OERIS™ demonstrated an 89% complete response rate, compared to 82% for the standard ondansetron arm, essentially translating to fewer incidences of emesis.
• - Safety Profile: Importantly, the trial reported no serious or severe adverse events linked to the use of OERIS™. Participants exhibited comparable or even superior tolerability in contrast to traditional methods.

Transformative Benefits of OERIS™

OERIS™ offers a significant advancement in CINV management, providing extended antiemetic protection through a singular injection that covers patients for up to five days. This long-lasting effect reduces the need for multiple daily doses or oral medication follow-ups, thus presenting a more convenient option for patients, which can improve compliance significantly.

Mr. Vishnukant Bhutada, Managing Director of Shilpa Medicare Limited stated, "We are proud to announce the successful completion of this pivotal Phase 3 study. OERIS™ 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."

Next Steps for Approval

Following these promising results, Shilpa Medicare plans to pursue regulatory approval with the Drug Controller General of India (DCGI). Additionally, the company is poised to seek global registration and commercialization through the 505(b)(2) pathway in the United States and other key markets.

Understanding CINV

CINV is a debilitating condition affecting 70-80% of patients undergoing chemotherapy. The market for CINV treatments is estimated to be around USD 375 million. Controlling CINV effectively is critical, as poorly managed symptoms can lead to treatment discontinuation and a diminished quality of life for patients. The advent of long-acting therapies like OERIS™ could thus radically transform patient care and treatment outcomes in oncology.

About Shilpa Medicare Limited

Shilpa Medicare is a prominent Indian pharmaceutical entity specializing in Active Pharmaceutical Ingredients (APIs), formulations, and biologics, particularly within oncology. Their ongoing innovations reflect a commitment to enhancing patient care through effective medical solutions.

For more information, visit Shilpa Medicare's official website.