Shilpa Medicare的OERISTM每周注射一次,在第三阶段试验中,在防止化疗恶心和呕吐方面显示出显著效果。
Shilpa Medicare's OERIS™, a weekly injection, showed strong results in preventing chemo nausea and vomiting in a Phase 3 trial.
Shilpa Medicare报告,OERISTM在第三阶段的试验结果是积极的。 OERISTM为预防化学疗法诱发的恶心和呕吐,每周注射一次。
Shilpa Medicare reported positive Phase 3 trial results for OERIS™, a once-weekly ondansetron injection that prevents chemotherapy-induced nausea and vomiting.
在对240名病人进行的一项研究中,OSRISTM实现了89%的完整答复率,而采用标准的onsetron的回答率为82%,持续120小时后进行化学后治疗,没有发生严重不良事件。
In a study of 240 patients, OERIS™ achieved an 89% complete response rate—compared to 82% with standard ondansetron—through 120 hours post-chemotherapy, with no serious adverse events.
该药物可有效控制急性和延迟的恶心和呕吐,一次剂量可达五天,从而方便病人。
The drug provided effective control of both acute and delayed nausea and vomiting for up to five days with a single dose, improving patient convenience.
该公司计划寻求印度DGGI的批准,并进行全球登记,包括通过美国505(b)(2)途径进行。
The company plans to seek approval from India’s DCGI and pursue global registration, including via the U.S. 505(b)(2) pathway.