Phase 3 PHALCON-NERD-301 study: Non-Erosive GERD NDA Submission

Heartburn can be a daily battle for millions of Americans, but new research provides hope for those suffering from Non-Erosive GERD. The Phase 3 PHALCON-NERD-301 study showed promising results for vonoprazan, with 10 mg and 20 mg doses providing symptom relief for the entire 6 months of the study. This breakthrough treatment could change the game for the estimated 38 million adults in the U.S. with Non-Erosive GERD. The safety profile of this drug was consistent with prior vonoprazan studies, giving even more hope for its future approval. If approved by the FDA, vonoprazan could soon become a daily treatment option for those struggling with heartburn and GERD. The FDA action date for the Non-Erosive GERD NDA is scheduled for the third quarter of 2024.