Santarus says diarrhea drug meets goal in study

Santarus's rifamycin drug works better than placebo in treating traveler's diarrhea in study

Associated Press

SAN DIEGO (AP) -- Santarus Inc. said Tuesday that its experimental traveler's diarrhea treatment met its goal in a late-stage clinical trial, as it worked better than a placebo.

The company said patients who took rifamycin SV MMX no longer had diarrhea 46 hours after they began taking the drug. Patients who took a placebo had their symptoms clear up after 68 hours. The trial involved 264 patients. Some of them were given 400 milligrams of rifamycin SV MMX twice a day for three days, and the rest were given two placebo pills twice a day for three days.

Traveler's diarrhea is usually caused by eating food or drinking water contaminated with particular strains of bacteria.

Santarus stock gained 29 cents, or 3.7 percent, to $8.09 in after-hours trading. The shares added 14 cents to $7.80 during the day.

Rifamycin is a type of antibiotic used to treat a variety of different illnesses. One rifamycin-based drug, rifaximin, is sold by Salix Pharmaceuticals Ltd. as a treatment for traveler's diarrhea and other conditions. Santarus' version of rifamycin is coated with polymers that delay the release of the drug until it is in the colon.

The most common side effects in patients treated with rifamycin SV MMX in the clinical trial included headache, diarrhea, infectious diarrhea, and constipation. Santarus said three patients experienced serious medical problems, although all three were determined to be unrelated to the drug: neuroblastoma, a type of cancer that forms in nerve tissue; abdominal pain; and vomiting.

Santarus said it will present more data from the study at a medical conference in 2013.

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