Shilpa Medicare Reports Success for OERIS Phase 3 Trial

Shilpa Medicare announced favorable topline Phase 3 results of its new drug OERIS (Ondansetron Extended Release Injection).

OERIS is a weekly medication that is used to prevent chemotherapy-induced nausea and vomiting (CINV). The multicentric randomized, and double-blind trial was conducted in a number of top-tier centers in India in terms of oncology.

It involved 240 patients who were undergoing moderately emetogenic or highly emetogenic chemotherapy. Eighty nine percent of the OERIS-treated patients had a complete response compared to 82 percent of patients receiving conventional treatment.

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No severe negative experiences were mentioned. The effective use of anti-emetic protection has been obtained through one injection that covers up to five days eliminating any necessity of taking many doses per day or oral medications. OERIS enhances patient convenience, increases compliance and simplifies clinical processes by streamlining schedules of treatment. This is a big step with regard to supportive cancer care.

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

Following these outcomes, Shilpa Medicare will apply with the Drugs Controller General of India (DCGI) to maintain the regulatory approval. The company will also use 505(b)(2) route to global registration and commercialization in the US and other major markets. Through OERIS, the firm will be one of the leaders in the creation of oncology-supportive therapies.