AXCAN PHARMA WINS FDA APPROVAL FOR PYLERA

Axcan Pharma announced that the FDA has approved the company's new drug application for Pylera. The drug is a patented three-in-one capsule for the eradication of Helicobacter pylori, which is a bacterium now recognized as being the main cause of gastric and duodenal ulcers. Each Pylera capsule contains biskalcitrate potassium (140 mg), metronidazole (125 mg) and tetracycline hydrochloride (125 mg).

The approval is based on Phase III North American trials conducted in 275 patients with a history of duodenal ulcer. The studies compared the Pylera regimen given in combination with two daily doses of 20 mg of omeprazole, to the widely used OAC triple therapy (20 mg of omeprazole, 1 g of amoxicillin and 500 mg of clarithromycin, all given twice a day).

Helicobacter pylori is believed to cause a spectrum of diseases in humans, including gastritis, ulcer disease (gastric and duodenal), gastric cancer and gastric lymphoma, according to the company. Existing ulcer treatment regimens lead to high recurrence rates. Studies have shown that the recurrence rate of peptic ulcers after one year is only 2 percent in patients in whom the organism has been eradicated.