FDA approves ‘more flexible Talicia regimen’ of three daily doses for H. pylori infection
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The FDA approved the supplemental new drug application for Talicia for Helicobacter pylori eradication, shortening the current dosing regimen to improve patient adherence, according to manufacturer RedHill Biopharma.
According to a company press release, the dosing regimen for Talicia (omeprazole magnesium, amoxicillin and rifabutin) has been updated to three times daily, taken at least 4 hours apart with food compared with the previous dosing of every 8 hours. The new dosing regimen follows a “breakfast, lunch and dinner” routine that may enhance patient adherence and improve H. pylori eradication efforts, the company noted.
“H. pylori treatment can be challenging for patients as most regimens require different pills to be taken multiple times per day,” Colin W. Howden, MD, professor emeritus at the University of Tennessee College of Medicine, said in the release. “However, it is clear that simplified regimens promote improved patient adherence and should be a key factor when considering choice of H. pylori eradication therapy.”
Howden added: “This new dosing regimen further supports the value of Talicia as an empirically prescribed first-line therapy for H. pylori eradication. Talicia’’s favorable efficacy, tolerability and resistance profile, as well as being the only all-in-one formulation available, provides potential advantages over clarithromycin-based regimens for most patients.”
The FDA based its approval on results of a pivotal phase 3 trial, in which Talicia demonstrated an 84% eradication of H. pylori infection in the intent-to-treat group compared with 58% in the active comparator group (P <.0001). Additionally, patients who were adherent to Talicia treatment exhibited a 90.3% response rate vs. a 64.7% response rate in the active comparator group.
“Talicia is unique in that it is the only FDA-approved rifabutin-based therapy for the eradication of H. pylori,” June Almenoff, MD, PhD, chief medical officer of RedHill Biopharma, said in the release. “Both its components and formulation are optimized to provide patients with the necessary medications for successful H. pylori eradication. ...We have demonstrated therapeutic equivalence between [three times a day] and [every 8 hours] dosing, enabling us to provide what we believe is a more flexible Talicia regimen that we believe will be beneficial for the patient experience.”
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