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news.Optimer Pharmaceuticals, a biopharmaceutical company, has announced positive results from the second of two double-blind pivotal Phase III trials assessing the safety and efficacy of Prulifloxacin 600mg as a once-daily, three-day oral therapy for the treatment of infectious diarrhea, including travelers' diarrhea.
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The top-line analysis of data from this study shows that Prulifloxacin met the study objective of superiority to placebo in the resolution of diarrhea, measured by time to last unformed stool (TLUS), the company said.
Prulifloxacin showed a statistically significant benefit compared to placebo in TLUS in both the modified intent-to-treat; n=200 and microbiologically evaluable (per protocol; n=173) populations. The median TLUS for patients treated with Prulifloxacin was 32.8 hours; this was significantly different from the TLUS for placebo with a p-value of <0.0001.
This trial also confirms the overall efficacy and safety profile observed in the previous Phase III trial, demonstrating that Prulifloxacin was generally well tolerated and had a similar safety profile compared to placebo, the company added.
Michael Chang, president and CEO of Optimer, said: With the completion of two successful Phase III trials showing superiority over placebo, Prulifloxacin may represent a welcomed addition for the treatment of infectious diarrhea. Having met the primary endpoint in both of our Prulifloxacin Phase III clinical trials, we believe the results are adequate to support a new drug application filing.
If approved, we believe Prulifloxacin will provide patients unique benefits versus current antibiotics for infectious diarrhea, such as a convenient, once-daily three-day treatment regimen.