Optimer Drug for Traveler’s Diarrhea Passes Key Trial, Will Seek FDA Approval

Xconomy San Diego — 

Here’s some potentially good news for vacationers who have had their trip spoiled by a bad case of the runs. Optimer Pharmaceuticals says its experimental drug for traveler’s diarrhea has reached its goal in a second pivotal clinical trial, and the San Diego-based firm plans to ask the FDA to approve the drug by the end of this year.

The drug, an antibiotic known as prulifloxacin, met its primary goal of the study to provide a faster end to traveler’s diarrhea (caused by bacteria such as E. coli and salmonella) for patients compared with those who took placebo. It took a median time of 32.8 hours for the drug to work, based on a measurement of how long it took for patients to have solid stools after taking the drug. Patients took the oral drug once a day for three days. The study—which took place in India, Mexico, and Guatemala—also confirmed earlier data that the drug was safe and well tolerated in patients, according to Optimer (NASDAQ:OPTR).

The positive trial follows the positive data Optimer revealed late last year for its separate, lead drug that showed it could kill off a bacteria called C. Diff that causes a potentially fatal form of diarrhea. Traveler’s diarrhea, while not as deadly, presents Optimer with a $200 million market, company executives told Luke last month. They added that while not a large, the market for traveler’s diarrhea has fewer competitors than other infectious disease businesses. One competitor, if prulifloxacin were approved, would be Bayer and its drug ciprofloxacin (Cipro), which Optimer executives argue is less potent than theirs.

Prulifloxacin, a fluoroquinolone antibiotic, is already in use Japan and Korea as an intravenous treatment for respiratory, urinary tract, and other infections. In 2004 Optimer acquired exclusive rights to develop and commercialize the antibiotic in the U.S. from Japanese drug-maker Nippon Shinyaku.

Optimer shares climbed 5 percent after the news to $11.20 shortly after the market opened. The company’s stock has almost tripled since late October on the positive results of the C. Diff drug and now with its treatment for traveler’s diarrhea.