A combination of omeprazole magnesium, amoxicillin, and rifabutin (Talicia, RedHill Biopharma Ltd.) has won FDA approval for the treatment of Helicobacter pylori infection in adults. The drug—the only rifabutin-based therapy approved for Helicobacter pylori infection—seeks to address the bacteria’s growing resistance to clarithromycin-based standard care, which more than doubled between 2009 and 2013.
The delayed-release oral capsules include 10 mg of the proton pump inhibitor omeprazole plus two antibiotics: 250 mg of amoxicillin and 12.5 mg of rifabutin.
Clinical studies demonstrated the drug’s high efficacy in eradicating H. pylori and zero resistance to rifabutin, compared with 17% resistance to the macrolide antibiotic clarithromycin, said lead investigator David Y. Graham, MD, MACG, Professor of Medicine, Molecular Virology, and Microbiology at Baylor College of Medicine in Houston. Other data show clarithromycin-containing therapies fail in about 25% to 40% of cases, he added.
The new drug combination’s approval is based, in part, on the results of two phase 3 studies for the treatment of H. pylori-positive adults complaining of epigastric pain, discomfort, or both. One study demonstrated 84% eradication of H. pylori infection with Talicia versus 58% in the active comparator arm, with response rates of 90.3% in the Talicia arm versus 64.7% in the active comparator arm at day 13. Adverse reactions leading to patients’ discontinuation of the new drug were nausea, vomiting, nasal congestion, and nasopharyngitis.
H. pylori is a major cause of peptic ulcer, gastritis, and gastric cancer.
Source: RedHill Biopharma, November 4, 2019