The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Talicia® to include a more flexible dosing regimen for the treatment of Helicobacter pylori (H. pylori) infection in adults.
Talicia may now be administered 3 times a day, taken at least 4 hours apart with food (eg, morning, mid-day, and evening), for 14 days. Previously, the dosing regimen required dosing every 8 hours with food.
The product is a 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. Talicia received FDA approval in March 2020 based on data from two phase 3 trials in H. pylori-positive adult patients complaining of epigastric pain and/or discomfort.
“Talicia is unique in that it is the only FDA-approved rifabutin-based therapy for the eradication of H. pylori,” said Dr June Almenoff, MD, PhD, RedHill’s Chief Medical Officer. “Through our successful collaboration with Certara, utilizing their Simcyp™ Simulator for physiologically based pharmacokinetic (PBPK) modeling, we have demonstrated therapeutic equivalence between TID and Q8H dosing, enabling us to provide what we believe is a more flexible Talicia regimen that we believe will be beneficial for the patient experience.”
Talicia is supplied in bottles containing 84 capsules.
- RedHill announces FDA sNDA approval for Talicia®. News release. RedHill Biopharma. September 18, 2023. https://www.prnewswire.com/news-releases/redhill-announces-fda-snda-approval-for-talicia-301930308.html.
- Talicia. Package insert. RedHill Biopharma; 2023. Accessed September 18, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213004s010lbl.pdf.