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Phathom Pharmaceuticals Announces Publication of Data from Phase 3 pHalcon-NERD-301 Study Showing VOQUEZNA® (vonoprazan) Improved Nocturnal GERD Symptoms in Patients with Non-Erosive Reflux Disease
Globenewswire· 2025-10-25 13:59
Core Insights - Phathom Pharmaceuticals announced the publication of additional analyses from its pivotal Phase 3 pHalcon-NERD-301 trial for VOQUEZNA (vonoprazan) in treating Non-Erosive Reflux Disease (NERD), highlighting its potential to alleviate nighttime GERD symptoms [1][8] Group 1: Clinical Findings - Nighttime GERD symptoms affect up to 80% of patients, leading to impaired sleep and increased health risks, yet many patients do not find relief with existing treatments [2][9] - The Phase 3 trial involved 772 patients, randomized to receive either VOQUEZNA (10 mg or 20 mg) or placebo, with significant findings on symptom relief [3][5] - VOQUEZNA demonstrated rapid and sustained relief of nighttime GERD symptoms, with heartburn-free nights increasing significantly after the first dose and maintained through 24 weeks [5][6] Group 2: Efficacy Data - At week 4, patients on VOQUEZNA 10 mg and 20 mg reported heartburn-free nights of 59.9% and 56.4%, respectively, compared to 43.3% for placebo [6] - Improvements in nocturnal symptom severity and sleep-related impacts were sustained throughout the treatment period, with median heartburn-free nights remaining above 70% [5][6] - VOQUEZNA was generally well tolerated, with common adverse events being mild and occurring in less than 5% of patients [6][7] Group 3: Product Information - VOQUEZNA is a potassium-competitive acid blocker (PCAB) approved for treating Erosive and Non-Erosive GERD, as well as H. pylori infection [10][30] - Approximately 38 million U.S. adults suffer from Non-Erosive GERD, with around 15 million receiving prescription treatment annually [9]