General Information

Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole).

Talicia is specifically indicated for the treatment of Helicobacter pylori infection in adults.

Talicia is supplied as a capsule for oral administration.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Administer four (4) Talicia capsules every 8 hours for 14 days with food. Patients should swallow the Talicia capsules whole, with a full glass of water (8 ounces). Each dose (4 capsules) of Talicia includes rifabutin 50 mg, amoxicillin 1,000 mg and omeprazole 40 mg. Do not crush or chew Talicia capsules. Do not take Talicia with alcohol. If a dose is missed, patients should continue the normal dosing schedule until the medication is completed. Do not take two doses at one time to make up for a missed dose.

Mechanism of Action

Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole).

Amoxicillin acts through the inhibition of cell wall biosynthesis that leads to the death of bacteria. Rifabutin inhibits DNA-dependent RNA polymerase in susceptible microorganisms but not in mammalian cells. Resistance to amoxicillin is mediated primarily through beta-lactamases that cleave the beta-lactam ring of amoxicillin, rendering it inactive. Resistance to rifabutin occurs through mutations in the DNA-dependent RNA polymerase.

Clinical Trial Results

The FDA approval of Talicia was based, in part, on the results of two positive Phase 3 studies in the U.S. for the treatment of H. pylori-positive adult patients complaining of epigastric pain and/or discomfort.

Study 1 was was a a randomized, double-blind, controlled study in treatment-naïve H. pylori-positive adult patients complaining of epigastric pain/discomfort. H. pylori infection at baseline was defined as positive by 13C urea breath test (UBT) and follow-up upper endoscopy (culture, histology, or Campylobacter-like organism test). Patients were randomized 1:1 to Talicia or control (total daily dose of amoxicillin 3000 mg and omeprazole 120 mg) administered for 14 consecutive days. The trial was performed in the U.S and designed to evaluate the added contribution of rifabutin to the Talicia triple combination. H. pylori eradication was confirmed with a negative 13C UBT or fecal antigen test performed ≥28 days posttherapy. Patients with negative test results were considered treatment successes. Patients who tested positive for H. pylori infection were considered treatment failures, and patients with indeterminate, not assessable, or missing results from the test of cure visits underwent a repeat 13C UBT test. Persistent indeterminate results and patients without any 13C UBT or fecal antigen test after baseline were considered as treatment failures. The difference in response rates between Talicia and the control was 26.1%.

Study 2 was a randomized, double-blind, placebo-controlled study of Talicia in H. pylori-positive adult patients complaining of epigastric pain/discomfort was performed in the U.S. and provided supportive evidence for the efficacy of Talicia for the treatment of H. pylori infection; 77 patients taking Talicia and 41 patients taking placebo were included in the ITT population, with an eradication rate of 76.6% the Talicia-treated patients compared to 2.4% for the placebo-treated patients. Eleven patients in the Talicia arm and four patients in the placebo arm were classified as treatment failures due to missing 13C UBT results at the test-of-cure visit.