General Information

Voquezna Triple Pak is a co-packaged product containing vonoprazan, a potassium-competitive acid blocker (PCAB), amoxicillin, a penicillin class antibacterial, and clarithromycin, a macrolide antimicrobial.

Voquezna Dual Pak is a co-packaged product containing vonoprazan, a potassium-competitive acid blocker (PCAB), amoxicillin, a penicillin class antibacterial.

Voquezna Triple Pak and Dual Pak are specifically indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults.

Voquezna Triple Pak and Dual Pak contain tablets for oral administration. The recommended dose is as follows:

• Voquezna Triple Pak: The recommended dosage regimen is vonoprazan 20 mg plus amoxicillin 1,000 mg plus clarithromycin 500 mg, each given twice daily (morning and evening, 12 hours apart), with or without food, for 14 days.
• Voquezna Dual Pak: The recommended dosage regimen is vonoprazan 20 mg twice daily (morning and evening) plus amoxicillin 1,000 mg, three times a day (morning, mid-day, and evening), with or without food, for 14 days.

Mechanism of Action

Vonoprazan suppresses basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell through inhibition of the H+, K+-ATPase enzyme system in a potassium competitive manner. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, vonoprazan has been characterized as a type of gastric proton-pump inhibitor, in that it blocks the final step of acid production. Vonoprazan does not require activation by acid. Vonoprazan may selectively concentrate in the parietal cells in both the resting and stimulated states. Vonoprazan binds to the active proton pumps in a noncovalent and reversible manner. Amoxicillin is an antibacterial drug. Clarithromycin is a macrolide antimicrobial drug. Acid suppression enhances the replication of H. pylori bacteria and the stability and effectiveness of antimicrobials in the treatment of H. pylori infection.

Side Effects

Voquezna Triple Pak: Most common adverse reactions were dysgeusia, diarrhea, vulvovaginal candidiasis, headache, abdominal pain, and hypertension.

Voquezna Dual Pak: Most common adverse reactions were diarrhea, abdominal pain, vulvovaginal candidiasis and nasopharyngitis.

Clinical Trial Results

These approvals were based on safety and efficacy data from the Phase 3 PHALCON-HP trial which randomized 1,046 patients. In the modified intent-to-treat population, both Voquezna treatment regimens demonstrated non-inferiority to lansoprazole triple therapy in patients without a clarithromycin or amoxicillin resistant strain of H. pylori at baseline. The H. pylori eradication rate was 84.7% with Voquezna Triple Pak compared to 78.8% with lansoprazole triple therapy and 78.5% for Voquezna Dual Pak compared to 78.8% with lansoprazole triple therapy. Voquezna Triple and Dual Pak demonstrated superior eradication rates compared to PPI-based triple therapy (lansoprazole with amoxicillin and clarithromycin) among all patients, including in patients with clarithromycin resistant strains of H. pylori. The H. pylori eradication rate with Voquezna Triple Pak was 80.8% versus 68.5% with lansoprazole triple therapy in the overall study population and in patients who had a clarithromycin-resistant strain of H. pylori, 65.8% vs. 31.9%, respectively. H. pylori eradication rates for Voquezna Dual Pak were 77.2% versus 68.5% with lansoprazole triple therapy in the overall study population and in patients who had a clarithromycin-resistant strain of H. pylori, 69.6% vs. 31.9%, respectively.