FDA Approves New Formulation of Acid Reflux Disease Treatment

The FDA last week approved a new proton pump inhibitor (PPI) manufactured by Takeda Pharmaceuticals.

Dexilant SoluTab, a new formulation of dexlansoprazole, is a delayed-release orally disintegrating tablet that treats heartburn in adults associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and erosive esophagitis.

The 30-mg tablet can maintain healing of EE and heartburn relief for up to 6 months, while also treating heartburn associated with GERD for 4 weeks.

"Our more than 20 years of leadership in gastroenterology has allowed us to provide another option that offers relief from heartburn associated with GERD in an orally disintegrating tablet," said Senior Vice President of Takeda, Thomas Gibbs. "This new formulation expands the Dexilant family and offers appropriate patients with GERD, who may struggle with swallowing capsules, a melt in your mouth alternative."

GERD, also known as acid reflux disease, is a chronic condition that affects approximately 20% of people in the United States. When the lower esophageal sphincter does not work correctly, GERD can occur. It can be characterized by persistent heartburn 2 or more days a week.

Dexilant, which is also available as a capsule, has been available for nearly 7 years with more than 25 million prescriptions filled since being approved by the FDA.