Voquezna Triple Pak and Dual Pak - 2 indications

Scroll down for more information on each condition:

• for the treatment of Helicobacter pylori (H. pylori) infection in adults; approved May of 2022
• for the treatment of erosive esophagitis, also known as Erosive GERD (gastroesophageal reflux disease); approved October of 2023
  

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.
• for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults and to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults

Voquezna Triple Pak and Dual Pak contain tablets for oral administration. Scroll down for recommended dosing.

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.

Indication 1 - for the treatment of Helicobacter pylori (H. pylori) infection 

approved May of 2022

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.

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.

Indication 2 - for the treatment of erosive esophagitis (Erosive GERD)

approved October of 2023

Maintenance of Healed Erosive Esophagitis and Relief of Heartburn: the recommended adult oral dosage is Voquezna 10 mg once daily for up to 6 months.

FDA approval was based on results from the Phase 3 PHALCON-EE study. The pivotal trial was a randomized, double-blind, multicenter study that enrolled 1,024 patients with Erosive GERD in the U.S. and Europe and compared Voquezna to the PPI lansoprazole in the healing and maintenance of healing of Erosive GERD and associated heartburn symptom relief. 

Results showed that Voquezna 20 mg met the primary endpoint of non-inferiority for complete healing by Week 8 in patients with all grades of Erosive GERD with a healing rate of 93% compared to 85% for lansoprazole 30 mg, with superior rates of healing demonstrated in a secondary endpoint in patients with moderate-to-severe disease (LA Grade C/D) at Week 2 compared to lansoprazole (70% for Voquezna 20 mg and 53% for lansoprazole 30 mg). Voquezna 20 mg also demonstrated non-inferiority to lansoprazole 30 mg in the mean percentage of 24-hour heartburn free days over the healing period. In the maintenance phase of the trial, Voquezna 10 mg was superior to lansoprazole 15 mg in maintaining healing at six months in all randomized patients (79% for Voquezna 10 mg, compared to 72% for lansoprazole 15 mg) as well as in the subset of patients with moderate-to-severe Erosive GERD (75% for Voquezna 10 mg, compared to 61% for lansoprazole 15 mg) (p=0.0490). In addition, Voquezna 10 mg was evaluated as a secondary endpoint for relief of heartburn in Erosive GERD patients and demonstrated non-inferiority to lansoprazole 15 mg over six months.