The US Food and Drug Administration (FDA) has approved Talicia (RedHill Biopharma Ltd), the first rifabutin-based treatment for Helicobacter pylori (H pylori) infection in adults, according to a company news release.
Each delayed-release capsule of Talicia contains omeprazole 10 mg (equivalent to 10.3 mg omeprazole magnesium), amoxicillin 250 mg, and rifabutin 12.5 mg.
Research has shown that resistance of H pylori to clarithromycin more than doubled between 2009 and 2013, the company said.
"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," David Graham, MD, professor of medicine, molecular virology, and microbiology at Baylor College of Medicine in Houston, Texas, who led the Talicia phase 3 studies, said in a news release from RedHill.
"The clinical studies for Talicia demonstrated high efficacy in eradication of H pylori. 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% to 40% of cases," said Graham.
The two phase 3 studies involved H pylori-positive adults complaining of epigastric pain and/or discomfort.
In the confirmatory phase 3 trial, 4 of 305 patients (1%) treated with Talicia stopped the medication due to an adverse reaction, the company said. Adverse reactions leading to discontinuation were nausea and vomiting, nasal congestion, and nasopharyngitis.
"Treatment of H pylori infection has become increasingly difficult due to growing bacterial resistance and the lack of advances in treatment options over the past decade," Colin Howden, MD, chief of gastroenterology at University of Tennessee Health Science Center in Memphis, said in the news release.
"Talicia offers a new effective treatment option to overcome bacterial resistance and provide optimal efficacy and I believe it could become a recommended, first-line standard-of-care treatment for H pylori infection," added Howden.
The company expects to launch Talicia in the US in the first quarter of 2020.
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Cite this: FDA OKs First Rifabutin-Based H pylori Therapy Talicia - Medscape - Nov 04, 2019.