Aptalis Pharma launches H. pylori treatment

BRIDGEWATER, N.J. — Aptalis Pharma has launched its 10-day drug therapy for treating a gastrointestinal bacterial infection and ulcer condition, the company said.

Aptalis announced the launch of Pylera 10 Day Therapy PAK (bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride). The drug is approved for use in combination with the proton-pump inhibitor omeprazole in patients with Helicobacter pylori infection and duodenal ulcer disease that is either active or has a history of occurring within the past five years, for eradicating H. pylori.

Aptalis called Pylera the only branded treatment option for the condition that does not contain the macrolide antibiotic clarithromycin. According to one study, 92% of patients who had a strain of H. pylori resistant to clarithromycin had been treated with a macrolide antibiotic in the past 10 years.

"Almost 20 years after the establishment of clarithromycin-based triple therapy for the eradication of Helicobacter pylori, eradication rates are declining with this therapy, due to increasing rates of clarithromycin-resistant H. pylori," Aptalis president and CEO Frank Verwiel said. "Given this, it is important for physicians and patients to have a convenient non-macrolide treatment option like Pylera for H. pylori in the 10 Day Therapy PAK."