Phathom announces vonoprazan NDA submission for non-erosive GERD

Phathom Pharmaceuticals announced the submission of an NDA to the FDA for vonoprazan as a daily treatment for Non-Erosive gastroesophageal reflux disease, GERD, in adults. The regulatory submission is supported by the positive data from the PHALCON-NERD-301 study, a Phase 3 study evaluating the efficacy and safety of vonoprazan for the daily treatment of adults with Non-Erosive GERD, NERD. Vonoprazan is an investigational first-in-class potassium-competitive acid blocker from a novel class of medicines that block acid secretion in the stomach. The effectiveness and safety of vonoprazan 10 mg and 20 mg given once daily in NERD was evaluated in a randomized, placebo-controlled, double-blind, 4-week trial with a 20-week blinded extension conducted in the United States in 772 adult patients. As previously reported, both vonoprazan doses met the primary endpoint for the mean percentage of heartburn free days over the 4-week placebo-controlled period at 45%, 44%, and 28% for vonoprazan 10 mg, vonoprazan 20 mg and placebo, respectively . As previously reported, the overall adverse events were comparable between vonoprazan and placebo during the 4-week placebo-controlled period of which the most common events were nausea, abdominal pain, constipation, and diarrhea, reported at or below 3% for either vonoprazan 10 mg or 20 mg doses. The most common adverse events reported for the two vonoprazan doses during the 20-week extension period were upper respiratory tract infection, sinusitis, influenza, urinary tract infection, nasopharyngitis, nausea, and gastroenteritis, reported at or below 5%. Phathom expects a 10-month regulatory review and if approved, anticipates a third quarter 2024 U.S. launch for vonoprazan as a daily treatment for Non-Erosive GERD. Phathom also plans to initiate an additional Phase 3 study to evaluate vonoprazan as an As Needed treatment for episodic heartburn relief in adults with Non-Erosive GERD, a novel dosing treatment regimen.