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# Phathom Pharma Heartburn Drug Expanded Use
- URL: https://www.fdaweb.com/phathom-pharma-heartburn-drug-expanded-use/
- Published: 2024-07-18T12:00:00.000Z
- Updated: 2026-09-14T14:35:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157384

FDA has approved a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) 10 mg tablets for relieving heartburn associated with non-erosive gastroesophageal reflux disease (non-erosive GERD) in adults. This is the third approval for Voquezna, having seen previous approvals for treating all severities of erosive esophagitis, and combination use with antibiotics for eradicating *Helicobacter pylori* infection.

The latest approval was based on data from a pivotal study that showed Voquezna significantly reduced heartburn episodes in patients with non-erosive GERD. The Phase 3 trial enrolled 772 adult patients with non-erosive GERD who experienced four or more days of heartburn per week, with the majority having six to seven days of heartburn per week, and compared patients treated with Voquezna 10 mg to those with placebo in the relief of heartburn over four weeks, according to the company. “The mean percentage of heartburn-free days for patients taking Voquezna was 45% versus 28% for placebo (p<0.001), and the median percentage of 24-hour heartburn-free days was 48% versus 17%, respectively,” it says.