Phathom Pharma Submits NDA To FDA For Vonoprazan To Treat Non-Erosive GERD

(RTTNews) - Phathom Pharmaceuticals, Inc. (PHAT), a biopharmaceutical company focused on gastrointestinal or GI diseases, announced Tuesday the submission of a New drug application or NDA to the U.S. Food and Drug Administration for vonoprazan as a daily treatment for Non-Erosive gastroesophageal reflux disease or GERD in adults.

Phathom expects a 10-month regulatory review. If approved, the company anticipates a third quarter 2024 U.S. launch for vonoprazan as a daily treatment for Non-Erosive GERD.

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 in adults with Non-Erosive GERD or NERD.

Vonoprazan is an investigational first-in-class potassium-competitive acid blocker or PCAB 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.

As announced earlier, both vonoprazan doses met the primary endpoint for the mean percentage of heartburn free days over the 4-week placebo-controlled period.

Terrie Curran, President and Chief Executive Officer at Phathom, said, "The submission of the NERD daily dosing NDA represents a major potential advancement for the estimated 38 million adults in the U.S. suffering from the symptoms of Non-Erosive GERD, many of whom are dissatisfied with currently available therapies. Our NDA is supported by the results of our successfully completed PHALCON-NERD-301 study, which demonstrated vonoprazan's durable 24-hour heartburn control over six months and reaffirmed its known safety profile."

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.

For More Such Health News, visit rttnews.com