Originally published by our sister publication Gastroenterology & Endoscopy News
This story was updated on July 30 with a comment from a gastroenterologist.
The FDA has approved vonoprazan (Voquenza, Phathom) 10-mg tablets for use in patients with nonerosive reflux disease. It can also be used with amoxicillin or amoxicillin-clavulanate to treat Helicobacter pylori infections in adults.
"This approval introduces a new option for practitioners to add to their armamentarium, said Larry E. Clark Jr., MD, a gastroenterologist with Gastroenterology Associates of Central Virginia, in Lynchburg. "As gastroenterologists, we see a large amount of referrals from primary care providers for patients with suboptimal control of GERD symptoms on PPIs," he said.
"Providers and patients are seeking not just endoscopic work ups but improvement in these symptoms. With Voquezna we now have the option to use the PCAB class of medicines in the United States for potential increased acid suppression. With the higher gastric pH comes the opportunity for symptomatic relief in the subset of patients needing greater acid suppression. The expanded indications for both nonerosive and erosive reflux disease will hopefully make the process of prescribing the PCAB class easier for providers."
This creates another potassium-competitive acid blocker option for erosive esophagitis and for H. pylori eradication.
The approval for use in patients with NERD follows positive results from the phase 3 PHALCON-NERD-301 trial (Clin Gastroenterol Hepatol 2024 May 14. doi:10.1016/j.cgh.2024.05.004). In the trial, 772 adults reporting heartburn for four or more days per week without erosive esophagitis were randomized to receive 10 or 20 mg of vonoprazan or placebo. After four weeks, placebo patients were re-randomized to receive either dose of vonoprazan, and patients in the intervention arms continued with their assigned doses.
For the first part of the trial, the researchers found that patients taking vonoprazan reported more heartburn-free days than those taking placebo (vonoprazan 10 mg: 44.8%; vonoprazan 20 mg, 44.4%; placebo, 27.7%; P<0.0001 for all). In the extension arm of the trial, the researchers found that the mean/median percentages of heartburn-free days were similar across the four treatment arms (61%-63%; 76%-79%).
The most common adverse reactions were abdominal pain, constipation, diarrhea, nausea and urinary tract infection. Patients in the trial extension also reported upper respiratory tract infection and sinusitis.
Updated prescribing information is available here.
Based on a Phathom press materials.