Talicia (omeprazole magnesium, amoxicillin and rifabutin delayed-release capsules) has been made available for the treatment of Helicobacter pylori (H. pylori) infection in adults, according to RedHill Biopharma.
The product is a novel, fixed-dose oral capsule that combines the antibiotics rifabutin (12.5mg) and amoxicillin (250mg), and the proton pump inhibitor omeprazole (10mg). Each dose (4 capsules) of Talicia includes rifabutin 50mg, amoxicillin 1000mg and omeprazole 40mg.
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). In patients with confirmed adherence to treatment, response rates were 90.3% and 64.7% for Talicia and the active comparator, respectively. In addition, no resistance to rifabutin was detected in the pivotal study.
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 is supplied in bottles containing 84 capsules.
“We are delighted to announce the availability of Talicia in pharmacies nationwide – the first new FDA-approved drug to combat H. pylori infection in over a decade,” said Rick Scruggs, Chief Commercial Officer of RedHill. “We are in the process of finalizing agreements with national payers and have put in place patient support programs to ensure patients and physicians have access to Talicia.”
For more information visit redhillbio.com.