FDA Approves New Dosing Regimen for the H. Pylori Drug Talicia

The FDA has approved a new dosing option for RedHill Biopharma’s Talicia to treat patients with Helicobactor pylori infection. The new regimen is three times daily, taken at least four hours apart with food. This allows for a “breakfast, lunch and dinner” routine, which the company said helps to support increased patient adherence. The previous dosing was every eight hours with food.

H. pylori is a bacterial infection of the stomach that affects about 35% of the U.S. population. Most people don’t have any symptoms from H. pylori infection, but for those who do, symptoms include stomach pain, nausea, loss of appetite, bloating and unintentional weight loss. H. pylori can lead to stomach ulcers and is a risk factor for certain types of stomach cancer. The World Health Organization classifies H. pylori as a group 1 carcinogen.

Talicia a fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). It is the only FDA-approved rifabutin-based therapy for the eradication of H. pylori, and company officials said it was designed to address H. pylori resistance to clarithromycin. It has retail cost of $816 for a supply of 168 capsules, according to Drugs.com.

In March 2023, RedHill Biopharma began a warranty program for patients taking Talicia, with a commitment to reimburse patient out-of-pocket costs if Talicia does not work. Company officials said at the time, the warranty is part of its efforts to increase patient access.

“H. pylori treatment can be challenging for patients as most regimens require different pills to be taken multiple times per day. 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,” Colin W. Howden, M.D., professor emeritus at University of Tennessee College of Medicine, said in a press release.

Data on the bioequivalence of Talicia’s two regimens, which used physiologically-based pharmacokinetic (PBPK) modeling, was presented in May 2023 at the Digestive Disease Week.

Talicia with the eight-hour dosing was approved November 2019 to treat H. pylori infection in adults. In the pivotal phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm. Minimal to zero resistance to rifabutin was detected. Patients who were confirmed adherent to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm.

No generic of Talicia is available. The company said in its release that Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034. The QIDP is an incentive program to promote the development of antibacterial and antifungal drugs for serious and life-threatening infections. It was part of the Generating Antibiotic Incentives Now Act in 2012.