Novel Acid Blocker Offers Fresh Hope in Fighting Stubborn H. pylori Infections

A new treatment approach has emerged in the battle against Helicobacter pylori, one of the most common bacterial infections affecting roughly 115 million Americans. The FDA’s approval of vonoprazan-based combination therapies marks a significant shift in how doctors can tackle this persistent pathogen that has become increasingly resistant to conventional antibiotics.

Why H. pylori Remains a Growing Challenge

For decades, proton pump inhibitors (PPIs) have been the standard backbone of H. pylori treatment regimens. However, eradication rates have declined to below 80% in recent years, largely due to mounting antibiotic resistance and insufficient acid suppression. This means nearly 1 in 4 patients treated with traditional PPI-based triple therapy still carry the infection after their course of antibiotics—a sobering reality that drives the search for better options.

Left untreated, this bacterial infection can progress to serious complications including peptic ulcers and non-cardia gastric cancer, making effective first-line therapy crucial.

A Different Approach: Potassium-Competitive Acid Blockers

The newly approved VOQUEZNA DUAL PAK represents a departure from conventional treatment philosophy. Rather than relying on older PPI technology, this co-packaged product combines vonoprazan—a potassium-competitive acid blocker (PCAB) and the first representative of its drug class approved in the U.S. in over three decades—with amoxicillin.

The VOQUEZNA DUAL PAK offers physicians flexibility by providing effective treatment without clarithromycin, an antibiotic that presents concerns for some patient populations. This dual-component regimen can achieve superior acid suppression levels in the stomach, potentially enhancing antibiotic effectiveness.

Clinical Evidence Behind the Approval

The approval hinged on data from PHALCON-HP, the largest U.S. registry trial for H. pylori treatment, which enrolled 1,046 patients. Results revealed compelling advantages over traditional lansoprazole-based triple therapy.

For the broader patient population, VOQUEZNA DUAL PAK achieved a 77.2% eradication rate compared to 68.5% with conventional PPI triple therapy. More impressively, in patients harboring clarithromycin-resistant strains—a growing clinical challenge—the new regimen achieved 69.6% success versus only 31.9% with standard treatment.

Adverse event profiles between the new vonoprazan regimen and traditional therapy were comparable, with diarrhea being the most frequently reported side effect across all treatment arms.

Addressing Antibiotic Resistance Head-On

As antibiotic-resistant H. pylori strains proliferate, having treatment alternatives that work through enhanced acid suppression becomes increasingly valuable. Vonoprazan achieves more potent and sustained acid suppression than conventional PPIs, a mechanism that theoretically improves antibiotic penetration and bacterial eradication.

Phathom Pharmaceuticals, which licensed the exclusive North American and European rights to vonoprazan from Japan-based Takeda, anticipates commercial availability of the VOQUEZNA DUAL PAK in the third quarter of 2022. The company has also submitted regulatory applications for vonoprazan in erosive esophagitis and is investigating its potential for non-erosive reflux disease.

What This Means for Patients and Clinicians

The approval provides gastroenterologists and primary care physicians with proven alternatives to address the limitations plaguing current H. pylori management. Two distinct treatment pathways—triple and dual regimens—allow individualized therapy selection based on patient-specific factors and resistance patterns.

For the millions of Americans unknowingly harboring H. pylori, this therapeutic advancement offers renewed hope that modern science can overcome the bacterial defenses that have allowed this infection to persist despite decades of treatment efforts.