Optimer Pharmaceuticals has announced positive Phase III data from a trial of Prulifloxacin for infectious diarrhea. The drug, which is given in a once-daily dose, met the primary endpoint, and had a safety profile similar to that of a placebo. The study was conducted in Mexico and Peru, in patients who had traveler's diarrhea.
"We are encouraged by the positive data, which shows superiority of Prulifloxacin over placebo," said Michael Chang, President and CEO of Optimer Pharmaceuticals. "We believe these results provide a solid foundation for pursuing a New Drug Application with the FDA, assuming similar data from a second Phase 3 trial."
- here's Optimer's release [1]
Related Articles:
Optimer pays $20M to axe deal with Par [2]
Optimer files IPO in bid to raise $86.3M [3]
Links:
[1] http://www.fiercebiotech.com/press-releases/optimer-pharmaceuticals-announces-positive-results-prulifloxacin-phase-3-study
[2] http://www.fiercebiotech.com/story/optimer-pays-20m-to-axe-deal-with-par/2007-02-27
[3] http://www.fiercebiotech.com/story/optimer-files-ipo-in-bid-to-raise-86.3m/2006-11-10