The Food and Drug Administration (FDA) has approved Voquezna™ Triple Pak™ (vonoprazan, amoxicillin, clarithromycin) and Voquezna™ Dual Pak™ (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection in adults.
Vonoprazan is an oral small molecule potassium-competitive acid blocker that has been shown to have rapid and durable antisecretory effects. Voquezna Triple Pak is a co-packaged product containing vonoprazan, amoxicillin, a penicillin class antibiotic, and clarithromycin, a macrolide antimicrobial. Voquezna Dual Pak is a co-packaged product containing vonoprazan and amoxicillin.
The approval was based on data from a randomized, controlled, double-blind triple therapy/open-label dual therapy, phase 3 study (ClinicalTrials.gov Identifier: NCT04167670), which compared the efficacy and safety of Voquezna Triple and Dual Pak with lansoprazole in combination with amoxicillin and clarithromycin in 1046 adults with H. pylori infection.
Patients were randomly assigned 1:1:1 to receive Voquezna Triple Pak (vonoprazan 20mg twice daily plus amoxicillin 1000mg twice daily plus clarithromycin 500mg twice daily), Voquezna Dual Pak (vonoprazan 20mg twice daily plus amoxicillin 1000mg three times daily), or lansoprazole 30mg twice daily plus amoxicillin 1000mg twice daily plus clarithromycin 500mg twice daily. Each treatment regimen was administered for 14 days.
Results showed that in the modified intent-to-treat (mITT) population, H. pylori eradication rates were 84.7% and 78.5% with Voquezna Triple and Dual Pak, respectively, in patients who did not have a clarithromycin or amoxicillin resistant strain of H. pylori at baseline compared with 78.8% with lansoprazole triple therapy (P <.0001 and P <.01 for non-inferiority [primary endpoint]).
Additionally, Voquezna Triple and Dual Pak were shown to be superior to lansoprazole triple therapy in patients who had a clarithromycin resistant strain of H. pylori at baseline and in the overall population with the following H. pylori eradication rates, respectively:
- Clarithromycin resistant strain at baseline: 65.8% and 69.6% vs 31.9% (both P <.0001);
- Overall population: 80.8% and 77.2% vs 68.5% (P =.0003 and P =.01, respectively).
The most common adverse reactions reported with Voquezna Triple Pak included dysgeusia, diarrhea, vulvovaginal candidiasis, headache, abdominal pain, and hypertension. Adverse events reported with Voquezna Dual Pak included diarrhea, abdominal pain, vulvovaginal candidiasis and nasopharyngitis.
Voquezna Triple Pak is supplied as a carton containing 56-tablets and 56-capsules divided into 14 daily dose blister cards. Each daily blister card contains 2 vonoprazan tablets (20mg each), 4 amoxicillin capsules (500mg each), and 2 clarithromycin tablets (500mg each).
Voquezna Dual Pak is supplied as a carton containing 28-tablets and 84-capsules divided into 14 daily dose blister cards. Each daily blister card contains 2 vonoprazan tablets (20mg each) and 6 amoxicillin capsules (500mg each).
The Company expects to launch both products in the third quarter of 2022.
- Phathom Pharmaceuticals announces FDA approval of Voquezna™ Triple Pak™ (vonoprazan, amoxicillin, clarithromycin) and Voquezna™ Dual Pak™ (vonoprazan, amoxicillin) for the treatment of H. pylori infection in adults. News release. Phathom Pharmaceuticals, Inc. Accessed May 3, 2022. https://www.globenewswire.com/news-release/2022/05/03/2435147/0/en/Phathom-Pharmaceuticals-Announces-FDA-Approval-of-VOQUEZNA-TRIPLE-PAK-vonoprazan-amoxicillin-clarithromycin-and-VOQUEZNA-DUAL-PAK-vonoprazan-amoxicillin-for-the-Treatment-of-H-pylo.html
- Voquezna™ Triple Pak™ and Voquezna™ Dual Pak™. Package insert. Phathom Pharmaceuticals, Inc.; 2022. Accessed May 3, 2022. http://www.phathompharma.com/wp-content/uploads/VOQUEZNA-TRIPLE-PAK-and-VOQUEZNA-DUAL-PAK-FDA-Final-Label-3.pdf