FDA Approves Reformulation of Vonoprazan Tablets for Therapeutic Treatment of Helicobacter Pylori

The FDA approved the Prior Approval Supplement (PAS) for reformulation of vonoprazan tablets for vonoprazan tablets, amoxicillin capsules, and clarithromycin tablets (Voquenza Triple Pak; Phathom Pharmaceuticals) as well as vonoprazan tablets and amoxicillin capsules (Voquenza Dual Pak; Phathom Pharmaceuticals) for the treatment of Helicobacter pylori (H. pylori) infection in adult patients. The treatment regimens contain antibiotics containing vonoprazan, a new potassium-competitive acid blocker and the first antacid in a new class of drugs approved in the United States in more than 30 years.

The approvals were based on safety and efficacy data from the Phase 3 PHALCON-HP trial (NCT04167670). A total of 1,046 patients enrolled with H. pylori were involved in the trial, with both regimens in the intention-to-treat group demonstrating non-inferiority to lansoprazole triple therapy in patients without clarithromycin or amoxicillin resistant strains. H. pylori at the beginning. THE H. pylori The eradication rate was 84.7% with vonoprazan tablets, amoxicillin capsules and clarithromycin tablets, compared to 78.8% with lansoprazole triple therapy, and 78.5% with vonoprazan tablets and amoxicillin capsules versus lansoprazole triple therapy.

Additionally, the regimens demonstrated improved eradication rates compared to proton pump inhibitor triple therapy (lansoprazole with amoxicillin and clarithromycin) in all patients, including patients with clarithromycin strains. resistant to clarithromycin.H. pylori. THE H. pylori The eradication rate with vonoprazan tablets, amoxicillin capsules and clarithromycin tablets was 80.8% compared to lansoprazole triple therapy (68.5%) in the overall study population, and 65.8% and 31.9%, respectively, in patients with a strain resistant to clarithromycin. Additionally, eradication rates under vonoprazan tablet and amoxicillin capsule treatment were higher than those of lansoprazole triple therapy (77.2% versus 68.5%, respectively), and patients with strain resistant to clarithromycin showed eradication rates of 69.6% and 31.9%, respectively.

We are very pleased with the FDA approval of our reformulated vonoprazan tablets for both [vonoprazan-based treatment regimens]2 new first-line therapeutic options that offer strongH. pylorieradication rate, said Terrie Curran, president and CEO of Phathom, in a press release. H. pyloriEradication failures are due to increasing antibiotic resistance, inadequate acid suppression, and complex treatment regimens. We are excited about [the vonoprazan-based treatment regimens]a new class of acid suppression therapy, which has the potential to address these issues and improveH. pylorieradication.

Adverse event (AE) rates for vonoprazan-based regimens were comparable to lansoprazole triple therapy in the trial. The most commonly reported AEs in the vonoprazan tablet, amoxicillin capsule and clarithromycin tablet, vonoprazan tablet and amoxicillin capsule and lansoprazole triple therapy groups were diarrhea (4.0%, 5.2%, 9.0%, 6%), dysgeusia (4.6%, 0.6%, 6.1%). %), vulvovaginal candidiasis (3.2%, 2.0%, 1.4%), abdominal pain (2.3%, 2.6%, 2.9%), headache (2.6 %, 1.4%, 1.4%), hypertension (2.0%, 1.1%, 0.9%). %)), and nasopharyngitis (0.3%, 2.0%, 0.9%).

Our teams are finalizing preparations for a combined December 2023 [US] commercial launch forH. pylorias well as the planned launch of vonoprazan for erosive products [gastroesophageal reflux disease]if approved, Curran said in the press release.

Reference

Biosoace. Phathom Pharmaceuticals announces FDA approval of reformulated Vonoprazan tablets for VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA DUAL PAK (vonoprazan, amoxicillin) for the treatment of H. pylori infection in adults. Press release. October 30, 2023. Accessed October 30, 2023. https://www.biospace.com/article/releases/phathom-pharmaceuticals-announces-fda-approval-of-reformulated-vonoprazan-tablets-for-voquezna-triple-pak – vonoprazan-amoxicillin-clarithromycin-and-vocezna-dual-pak-vonoprazan-amoxicillin-for-the-treatment-of-h-pylori-infection-in-adults/