The US Food and Drug Administration (FDA) approved Voquezna (vonoprazan, Phathom Pharmaceuticals) 10-mg tablets for the relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults.
It represents the third indication for the potassium-competitive acid blocker, which is already approved to treat all severities of erosive esophagitis and to eradicate Helicobacter pylori infection in combination with antibiotics.
The approval in nonerosive GERD was supported by results of the PHALCON-nonerosive GERD-301 study, a phase 3 randomized, placebo-controlled, double-blind, multicenter study evaluating the safety and efficacy of once-daily Voquezna in more than 700 adults with nonerosive GERD experiencing at least 4 days of heartburn per week.
“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,” the study team wrote in a paper published online in Clinical Gastroenterology and Hepatology, and reported on by Medscape Medical News.
Voquezna “provides physicians with 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, University of Tennessee College of Medicine in Memphis, said in a news release.
The most common adverse events reported in patients treated with Voquezna during the 4-week placebo-controlled period were abdominal pain, constipation, diarrhea, nausea, and urinary tract infection.
Upper respiratory tract infection and sinusitis were also reported in patients who taking Voquezna in the 20-week extension phase of the trial.
Full prescribing information is available online.
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