Phathom Pharmaceuticals, Inc. received FDA approval for the Prior Approval Supplement (PAS) regarding the reformulation of vonoprazan tablets for both VOQUEZNA TRIPLE PAK (consisting of vonoprazan tablets, amoxicillin capsules, and clarithromycin tablets) and VOQUEZNA DUAL PAK (featuring vonoprazan tablets and amoxicillin capsules). These formulations are designed for the treatment of Helicobacter pylori (H. pylori) infection in adults. Notably, VOQUEZNA treatment regimens combine antibiotics with vonoprazan, a novel potassium-competitive acid blocker (PCAB). This marks the first innovative acid suppressant from a new drug class to be approved in the U.S. in over 30 years.
These initial product approvals are based on compelling safety and efficacy data from the Phase 3 PHALCON-HP trial, which stands as the largest registrational trial for H. pylori ever conducted in the U.S. involving 1,046 patients. In the modified intent-to-treat population, both VOQUEZNA treatment regimens have 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 rates are as follows:
- VOQUEZNA TRIPLE PAK: 84.7% compared to 78.8% with lansoprazole triple therapy
- VOQUEZNA DUAL PAK: 78.5% compared to 78.8% with lansoprazole triple therapy
Furthermore, both VOQUEZNA TRIPLE PAK and DUAL PAK have shown superior eradication rates compared to PPI-based triple therapy, even among patients with clarithromycin resistant strains of H. pylori.
Adverse event rates for the vonoprazan-based regimens were similar to those observed with lansoprazole triple therapy. The most common adverse events reported include diarrhea, dysgeusia, vulvovaginal candidiasis, abdominal pain, headache, hypertension, and nasopharyngitis.
VOQUEZNA TRIPLE and DUAL PAKs are anticipated to be available in the U.S. by December 2023, exclusively marketed by Phathom Pharmaceuticals, Inc. The company is also preparing for a combined U.S. commercial launch of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, along with vonoprazan for Erosive GERD, pending approval.