FDA expands Voquezna approval for heartburn relief in non-erosive GERD
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The FDA has expanded approval for Phathom Pharmaceuticals’ Voquezna tablets 10 mg to alleviate heartburn related in non-erosive gastroesophageal reflux disease, according to a company press release.
This is the third approved indication for Voquezna (vonoprazan) following FDA approvals in 2023 for the treatment of all severities of erosive esophagitis and Helicobacter pylori infection when combined with antibiotics.
“Millions of patients with non-erosive GERD continue to suffer from heartburn despite current treatment options,” Colin W. Howden, MD, professor emeritus from the University of Tennessee College of Medicine, said in the release. “The pivotal study that led to this approval showed that Voquenza significantly reduced heartburn episodes in patients with non-erosive GERD along with an established safety profile. [This] approval of Voquenza provides physicians with a novel, first-in-class treatment that can quickly and significantly reduce heartburn for many adult patients.”
The FDA based its decision on positive results from the PHALCON-NERD-301 trial, a phase 3 randomized, placebo-controlled, double-blind, which assessed the efficacy and safety of Voquezna among 772 patients with non-erosive GERD experiencing 4 or more days of heartburn per week. To evaluate the effect on heartburn relief, patients were randomly assigned to either Voquezna 10 mg or placebo over 4 weeks, followed by a 20-week extension period during which all patients received Voquenza.
According to pivotal trial results, Voquezna “quickly and significantly reduced heartburn with daily treatment through week 4.” Further, Voquezna met the primary endpoint of more complete all-day and all-night heartburn-free days as well as significantly more 24-hour heartburn-free days through week 4 compared with placebo.
Results showed that patients treated with placebo exhibited a greater mean percentage of heartburn-free days vs. placebo (45% vs. 28%) as well as an improved median percentage of 24-hour heartburn-free days (48% vs. 17%). Additionally, improvements in the percentage of each of the heartburn-free days and nights and percentage of days without rescue antacid use were reported in patients receiving Voquezna.
According to the release, during the 4-week placebo-controlled trial, the most common adverse events in those treated with Voquezna included abdominal pain, constipation, diarrhea, nausea and urinary tract infection, with upper respiratory tract infection and sinusitis reported in the 20-week extension period.
“[This] marks a significant milestone for millions of GERD patients as we proudly announce the approval of Voquezna for the treatment of non-erosive GERD,” Terrie Curran, president, and CEO at Phathom, said in the release. “For decades, GERD sufferers had no new class of treatment to turn to in the U.S. This approval provides patients and health care providers with immediate access to the first and only FDA-approved treatment of its kind, from a new class of acid suppression therapy, and the power to help provide complete 24-hour heartburn-free days and nights.”
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