Gastroesophageal reflux disease (GERD) patients have a new treatment option with the recent FDA approval of Voquezna (vonoprazan) 10-mg tablets for the relief of heartburn associated with nonerosive GERD in adults. This approval marks the third indication for vonoprazan, a potassium-competitive acid blocker, which is already approved for treating all severities of erosive esophagitis and eradicating Helicobacter pylori infection when used in combination with antibiotics.
The approval of Voquezna for nonerosive GERD was supported by results from the PHALCON-nonerosive GERD-301 study, a phase 3 randomized, placebo-controlled, double-blind, multicenter trial. The study evaluated the safety and efficacy of once-daily Voquezna in over 700 adults who experienced at least four days of heartburn per week. According to the study team, “Vonoprazan was efficacious in reducing heartburn symptoms in patients with nonerosive GERD, with the benefit appearing to begin as early as the first day of therapy. This treatment effect persisted after the initial 4-week placebo-controlled period throughout the 20-week extension period.”
Gastroesophageal Relief and Study Results
The findings were published online in Clinical Gastroenterology and Hepatology and reported by Medscape Medical News. Voquezna offers physicians a novel, first-in-class treatment that can quickly and significantly reduce heartburn for many adult patients with nonerosive GERD. Colin W. Howden, MD, professor emeritus at the University of Tennessee College of Medicine in Memphis, highlighted the potential of Voquezna, saying it “provides physicians with a novel, first-in-class treatment that can quickly and significantly reduce heartburn for many adult patients with nonerosive GERD.”
The study team reported that the most common adverse events during the 4-week placebo-controlled period were abdominal pain, constipation, diarrhea, nausea, and urinary tract infection. During the 20-week extension phase, upper respiratory tract infection and sinusitis were also reported among patients taking Voquezna.
The PHALCON-nonerosive GERD-301 study provided substantial evidence supporting the efficacy and safety of Voquezna. This phase 3 trial was crucial in demonstrating that vonoprazan could effectively reduce heartburn symptoms in patients suffering from nonerosive GERD. The randomized, placebo-controlled, double-blind, multicenter study involved more than 700 adults who experienced heartburn at least four days per week. The positive outcomes from this trial played a significant role in the FDA’s approval decision.
Vonoprazan’s ability to provide rapid symptom relief was particularly noteworthy. The study team observed that the benefits began as early as the first day of therapy and continued throughout the 20-week extension period following the initial 4-week placebo-controlled phase. These findings were published in Clinical Gastroenterology and Hepatology and highlighted by Medscape Medical News.
Gastroesophageal Approval’s Impact and Adverse Events
Colin W. Howden, MD, emphasized the significance of Voquezna in the treatment landscape, noting that it offers a new, effective option for patients with nonerosive GERD. The approval of Voquezna adds to the growing arsenal of treatments available for managing GERD, particularly for those patients who suffer from nonerosive forms of the disease.
The FDA’s approval of Voquezna for nonerosive GERD underscores the importance of providing effective treatment options for this common condition. GERD affects millions of people worldwide, and finding a reliable treatment that can quickly alleviate symptoms is a significant advancement.
While Voquezna has shown great promise in reducing heartburn symptoms, it is essential to consider the reported adverse events. During the 4-week placebo-controlled period, common adverse events included abdominal pain, constipation, diarrhea, nausea, and urinary tract infection. In the 20-week extension phase, some patients reported upper respiratory tract infections and sinusitis. However, these adverse events were generally manageable and did not overshadow the overall benefits of the treatment.
The FDA’s approval of Voquezna for nonerosive GERD provides a new, valuable tool for healthcare providers in managing this condition. With its rapid onset of action and sustained efficacy, Voquezna offers hope for many patients seeking relief from chronic heartburn associated with nonerosive GERD. This development marks a significant milestone in the ongoing efforts to improve the quality of life for individuals suffering from gastroesophageal reflux disease.
Resource: <a href="https://investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-announces-fda-approval-voqueznar-0″>Phathom Pharma, July 18, 2024

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