Omeprazole/Amoxicillin/Rifabutin Combination Capsule Receives FDA Approval for H pylori Treatment

Helicobacter pylori
Helicobacter pylori
The FDA has approved omeprazole magnesium, amoxicillin and rifabutin delayed-release capsules for the treatment of H pylori infection in adults.

The Food and Drug Administration (FDA) has approved Talicia (omeprazole magnesium, amoxicillin and rifabutin delayed-release capsules; RedHill Biopharma) for the treatment of Helicobacter pylori (H pylori) infection in adults.

Talicia is a novel, fixed-dose oral capsule that combines the antibiotics rifabutin (12.5mg) and amoxicillin (250mg), and the proton pump inhibitor omeprazole (10mg). The approval was based on data from two phase 3 trials in H pylori-positive adult patients complaining of epigastric pain and/or discomfort. In the confirmatory trial, the rifabutin-based therapy demonstrated 84% eradication of H pylori infection compared with 58% in the active comparator arm (amoxicillin 250mg and omeprazole 10mg)  (P<.0001).

With regard to safety, the most common treatment-emergent adverse reactions reported in studies included diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.

“Talicia offers patients a much-needed new treatment option for H pylori with an excellent safety and efficacy profile that is not compromised by clarithromycin or metronidazole resistance,” said David Y. Graham, MD, MACG, Professor of Medicine, Molecular Virology and Microbiology at Baylor College of Medicine, Houston and Lead Investigator of the Talicia phase 3 studies. “Studies with Talicia found zero resistance to rifabutin and showed 17% resistance to clarithromycin, a current standard-of-care macrolide antibiotic, consistent with current data showing that clarithromycin-containing therapies fail in approximately 25-40% of cases.”

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Talicia is expected to be available as 10mg/250mg/12.5mg delayed-release capsules in the first quarter of 2020. 

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This article originally appeared on MPR