Tuesday, Optimer Pharmaceuticals, Inc. (OPTR) announced positive results from the second of the two late-stage trials, which evaluated the safety and efficacy of Prulifloxacin for the treatment of infectious diarrhea, including travelers' diarrhea.
Infectious diarrhea can be caused through infection by bacteria, viruses or parasites. Travelers' diarrhea is infectious diarrhea contracted by the ingestion of contaminated food or water by travelers to a developing country.
The rights to develop and commercialize the broad-spectrum antibiotic Prulifloxacin in the U.S. was acquired by Optimer from Nippon Shinyaku Co., Ltd., in June 2004.
According to the results of the second phase III trial dubbed OPT-099-002, Prulifloxacin of dosage 600 mg as a once-daily, three-day oral therapy met the study objective of superiority to placebo in the resolution of diarrhea, measured by Time to Last Unformed Stool.
The company noted that the trial results confirm the overall efficacy and safety profile observed in the previous Phase 3 trial, referenced as OPT-099-001, the results of which were announced in July 2008.
Optimer said it is planning to file a new drug application for Prulifloxacin by the end of this year.
OPTR closed Monday's trade at $10.66.
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