Phathom Pharmaceuticals Secures FDA Approval for VOQUEZNA® (vonoprazan) Tablets to Alleviate Heartburn from Non-Erosive GERD in Adults
Friday, July 19, 2024
Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical firm specializing in innovative treatments for gastrointestinal (GI) conditions, has received FDA approval for VOQUEZNA® (vonoprazan) 10 mg tablets. This approval is for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults. Non-Erosive GERD, a common type of GERD, impacts millions in the U.S. who suffer from frequent heartburn. This marks the third FDA approval for VOQUEZNA, which is also approved for treating all levels of Erosive Esophagitis (Erosive GERD) and, in combination with antibiotics, for eradicating Helicobacter pylori (H. pylori) infection.
Terrie Curran, Phathom's President and CEO, highlighted the importance of this development, saying, “The FDA's approval of VOQUEZNA for Non-Erosive GERD represents a significant advancement for many GERD patients. For years, there have been no new classes of GERD treatments available in the U.S., and this new therapy offers a fresh option for achieving complete heartburn relief around the clock.”
Non-Erosive GERD is the largest subgroup of GERD, marked by reflux symptoms without visible esophageal damage. An estimated 45 million adults in the U.S. suffer from this condition, with about 15 million receiving prescription treatments annually. Despite existing options, many patients still experience heartburn that affects their daily life.
Dr. Colin W. Howden, Professor Emeritus at the University of Tennessee College of Medicine, commented, “VOQUEZNA has proven effective in reducing heartburn episodes in patients with Non-Erosive GERD and comes with a well-established safety profile. This approval introduces a novel treatment that can significantly improve heartburn relief for many adult patients.”
The approval is based on results from the PHALCON-NERD-301 study (NCT05195528), a Phase 3 trial that evaluated VOQUEZNA’s effectiveness and safety in treating Non-Erosive GERD. This study involved 772 adults with frequent heartburn and compared VOQUEZNA 10 mg to a placebo over a four-week period. VOQUEZNA showed a significant increase in the number of heartburn-free days compared to placebo, with a mean percentage of heartburn-free days of 45% for VOQUEZNA versus 28% for placebo. Patients on VOQUEZNA also experienced a higher median percentage of 24-hour heartburn-free days and improvements in overall heartburn relief.
The most common side effects observed in the trial included abdominal pain, constipation, diarrhea, nausea, and urinary tract infection. Additionally, upper respiratory tract infections and sinusitis were noted during the extended phase of the study.
Phathom offers support programs for patients facing coverage or affordability challenges, including co-pay assistance for those with commercial insurance. For more details, visit www.voquezna.com/savings.
VOQUEZNA is exclusively marketed by Phathom Pharmaceuticals and is available by prescription. More information can be found at www.voquezna.com.
The PHALCON-NERD-301 study was a Phase 3, randomized, double-blind trial conducted across multiple centers in the U.S. It assessed the percentage of days without heartburn over four weeks in patients with Non-Erosive GERD and included a 20-week extension to evaluate long-term treatment outcomes. The study enrolled 776 patients with frequent heartburn.
Non-Erosive GERD is the most common form of GERD and is characterized by reflux symptoms without esophageal damage. With over 65 million U.S. patients with GERD, approximately 70% have Non-Erosive GERD, which can severely impact quality of life with symptoms like episodic heartburn, regurgitation, difficulty swallowing, and chest pain.
VOQUEZNA® (vonoprazan) tablets contain vonoprazan, a novel potassium-competitive acid blocker (PCAB) that inhibits stomach acid production. It is approved for treating Erosive Esophagitis, relieving heartburn associated with both Erosive and Non-Erosive GERD, and for H. pylori infection in combination with specific antibiotics. Phathom obtained the U.S. rights to vonoprazan from Takeda, which markets the medication in Japan and several other regions in Asia and Latin America.
Source: globenewswire.com
