Shilpa Medicare aims for US approval of chemo nausea drug

Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections

Shilpa Medicare Limited intends to seek US approval for its Ondansetron Extended-Release Injection (OERIS) within the next two years and is currently looking for licensing partners. This follows a successful Phase 3 study in India where the drug candidate met all primary and secondary endpoints.

OERIS is a type of extended-release serotonin 5-HT3 receptor antagonist, a drug class used to stop nausea and vomiting from chemotherapy (CINV) by blocking serotonin's effects in the gut and brain, offering sustained relief by inhibiting those specific vomiting signals. These drugs, like ondansetron or palonosetron, are key antiemetics, often combined with steroids (dexamethasone) and NK1 blockers for better CINV control, targeting both acute and delayed symptoms effectively.

The phase 3 study evaluated the extended release injection against conventional ondansetron injections – which require multiple daily doses or oral follow-ups – and demonstrated sustained antiemetic coverage through a single dose, effective in both acute and delayed phases of CINV for up to five days.

The OERIS formulation is engineered to enhance safety and tolerability through a sustained, steady delivery of medication over time. This smooth release profile effectively minimizes high peak plasma concentrations, which are often linked to adverse effects such as QTc prolongation or concentration-dependent issues like constipation.

By reducing the typical fluctuations between peak and trough levels observed with conventional immediate-release ondansetron, OERIS significantly lowers the risk of associated side effects, including potential cardiac events or gastrointestinal issues.

“By reducing injection frequency and simplifying dosing schedules, OERIS significantly enhances patient convenience, reduces treatment burden, and improves compliance while optimizing healthcare workflow efficiency. We are now in the process of filing for regulatory approval in India, and will then seek global registration and commercial partnerships through the 505(b)(2) pathway in the United States and other key markets,” commented Mr. Vishnukant Bhutada, Managing Director, Shilpa Medicare Limited. “OERIS™ exemplifies Shilpa’s ability to combine scientific innovation with patient-centric design, and is yet another success for one of our innovative oncology programmes.”