Phathom Pharmaceuticals, Inc. has proudly disclosed that the FDA accepted the New Drug Application (NDA) for VOQUEZNA (vonoprazan). This oral medication is intended for daily use in treating heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (GERD) in adults. The FDA has slated the application for a standard 10-month review period, setting a target action date under the Prescription Drug User Fee Act (PDUFA) for July 19, 2024.
Non-Erosive GERD represents the largest subset of GERD, marked by reflux-related symptoms in the absence of esophageal mucosal erosions. Approximately 38 million adults in the U.S. grapple with Non-Erosive GERD, with roughly 15 million receiving a diagnosis and prescription medication annually. The symptoms significantly impact individuals' overall quality of life, manifesting as episodic heartburn—particularly at night—regurgitation, difficulties in swallowing, and chest pain.
In tandem with this development, Phathom is in the finalization stages of plans to initiate an additional Phase 3 study in 2024. This study will assess VOQUEZNA as an investigational As Needed treatment for providing episodic relief from heartburn in adults with Non-Erosive GERD. This novel dosing regimen stands out, especially as proton pump inhibitors (PPIs) do not currently have U.S. approval for this particular application.