FDA Approves Voquezna (vonoprazan) for Heartburn Relief in Non-Erosive GERD
核心洞察
The FDA has approved Voquezna (vonoprazan) 10 mg tablets for heartburn relief associated with Non-Erosive GERD in adults, marking a new option for millions.
Voquezna demonstrated a significant reduction in heartburn episodes in a Phase 3 trial, offering more 24-hour heartburn-free days compared to placebo.
The approval is based on the PHALCON-NERD-301 study, which showed Voquezna's efficacy and safety over a four-week treatment period.
Phathom Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Voquezna (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (搜索) (Non-Erosive GERD) in adults. This approval marks the third indication for Voquezna, which is also approved for Erosive Esophagitis (搜索) and H. pylori eradication, and introduces a new class of acid suppression therapy for GERD patients.
Non-Erosive GERD affects millions of individuals in the U.S., characterized by reflux-related symptoms without esophageal erosions. An estimated 45 million U.S. adults live with Non-Erosive GERD, with approximately 15 million seeking prescription treatment annually. Many patients remain dissatisfied with current therapies, highlighting the need for novel treatment options.
Clinical Trial Data
The approval is supported by results from the Phase 3 PHALCON-NERD-301 study (NCT05195528), a randomized, double-blind, placebo-controlled trial. The study evaluated the efficacy and safety of Voquezna in 772 adults with Non-Erosive GERD experiencing four or more days of heartburn per week. Patients were treated with Voquezna 10 mg or placebo for four weeks, with a 20-week extension period for long-term evaluation.
Voquezna demonstrated a significant reduction in heartburn, with a mean percentage of 45% heartburn-free days compared to 28% for placebo (p<0.001). The median percentage of 24-hour heartburn-free days was 48% for Voquezna versus 17% for placebo. Improvements were also observed in heartburn-free days and nights and reduced antacid use.
Safety and Tolerability
The most common adverse reactions (≥2%) reported in patients treated with Voquezna during the four-week placebo-controlled trial included abdominal pain, constipation, diarrhea, nausea, and urinary tract infection. Upper respiratory tract infection and sinusitis were also reported during the 20-week extension phase.
Mechanism of Action
Voquezna (vonoprazan) is a potassium-competitive acid blocker (PCAB), a novel class of drugs that block acid secretion in the stomach. This mechanism provides a new approach to managing acid-related conditions compared to traditional proton pump inhibitors (PPIs).
Expert Commentary
"Millions of patients with Non-Erosive GERD continue to suffer from heartburn despite current treatment options," said Colin W. Howden, M.D., Professor Emeritus, University of Tennessee College of Medicine. "The pivotal study that led to this approval showed that Voquezna significantly reduced heartburn episodes in patients with Non-Erosive GERD along with an established safety profile. Today’s approval of Voquezna provides physicians with a novel, first-in-class treatment that can quickly and significantly reduce heartburn for many adult patients."
Market Availability
Voquezna is marketed exclusively by Phathom Pharmaceuticals and is available via prescription. Phathom offers savings programs for eligible patients facing coverage or affordability issues.