Favorable safety and tolerability

• Adverse reactions leading to discontinuation of Talicia were nausea and vomiting, nausea, nasal congestion, and nasopharyngitis, in one patient each.

• Treatment discontinuation due to an adverse reaction occurred in 1% (4/305) of patients receiving Talicia, <1% (1/227) of patients receiving amoxicillin and omeprazole, and 2% (1/41) of patients receiving placebo.

Chromaturia can occur due to the rifabutin component of Talicia and some of its metabolites. Urine, feces, saliva, sputum, perspiration, tears, and skin may be colored brown-orange during therapy but should resolve after therapy is completed.

• Riboflavin was administered in Study 1 to prevent unintentional unblinding and may have contributed to under-reporting of chromaturia.