The New Drug Applications for vonoprazan triple therapy (in combination with amoxicillin and clarithromycin) and dual therapy (in combination with amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection in adults have been submitted to the Food and Drug Administration.
Vonoprazan is an oral small molecule potassium-competitive acid blocker that has been shown to have rapid and durable antisecretory effects. The applications are based on data from the phase 3 PHALCON-HP trial (ClinicalTrials.gov Identifier: NCT04167670), which compared the efficacy and safety of vonoprazan triple and dual therapies with lansoprazole in combination with amoxicillin and clarithromycin. Each treatment regimen was administered for 14 days.
Results from the trial showed that both vonoprazan triple and dual therapies met the primary noninferiority endpoints and all secondary endpoints. Additionally, both vonoprazan-based regimens were found to be superior to lansoprazole triple therapy in a subset of patients with H. pylori strains resistant to clarithromycin.
“The submission of these NDAs is the first step towards addressing the declining H. pylori eradication rates in the US and providing new potential treatment options for the millions of H. pylori sufferers in need of more efficacious treatments,” said Azmi Nabulsi, MD, Chief Operating Officer at Phathom. “If approved, we anticipate launch in the US in the second half of 2022.”
Phathom Pharmaceuticals submits two NDAs to US FDA for vonoprazan-based treatment regimens for the treatment of H. pylori infection. News release. Phathom Pharmaceuticals, Inc. Accessed September 8, 2021. https://www.globenewswire.com/news-release/2021/09/08/2293340/0/en/Phathom-Pharmaceuticals-Submits-Two-NDAs-to-U-S-FDA-for-Vonoprazan-based-Treatment-Regimens-for-the-Treatment-of-H-pylori-Infection.html.