Dexlansoprazole (Dexilant) Soluble Tablets Win FDA Nod for GERD-Associated Heartburn

SoluTab provides two separate releases of medication

The FDA has approved Dexilant SoluTab delayed-release orally disintegrating tablets (Takeda Pharmaceuticals U.S.A.), a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient’s mouth. The product is a proton pump inhibitor (PPI) indicated for the treatment of heartburn associated with symptomatic nonerosive gastroesophageal reflux disease (GERD) and for the maintenance of healed erosive esophagitis (EE) and the relief of heartburn in adults 18 years of age and older.

Dexilant SoluTab is a PPI with dual delayed-release technology that is designed to provide two separate releases of medication.

In addition to Dexilant SoluTab, dexlansoprazole is available as a capsule, which is indicated for heartburn associated with symptomatic nonerosive GERD, the healing of EE, and the maintenance of healed EE in adults. Since being approved by the FDA, Dexilant capsules have been available for nearly seven years, with more than 25 million prescriptions filled.

Dexilant SoluTab 30-mg delayed-release orally disintegrating tablets are indicated for maintaining the healing of EE and the relief of heartburn for up to six months, and for treating heartburn associated with symptomatic nonerosive GERD for four weeks

Dexilant 30-mg and 60-mg delayed-release capsules are indicated for healing all grades of EE for up to eight weeks; for maintaining the healing of EE and the relief of heartburn for up to six months; and for treating heartburn associated with symptomatic nonerosive GERD for four weeks.

Two 30-mg Dexilant SoluTabs are not interchangeable with one 60-mg Dexilant capsule.

GERD is a chronic condition commonly known as acid reflux disease. It affects approximately 20% of the U.S. population and is often characterized by frequent and persistent heartburn two or more days a week despite treatment and diet changes. GERD can occur when the valve at the lower end of the esophagus, called the lower esophageal sphincter (LES), does not work properly. This valve opens to allow food and liquids to enter the stomach and closes to keep acid and food in the stomach. When the LES does not close as tightly as it should, or relaxes too often, it can cause stomach contents to get into the esophagus.

Source: Takeda Pharmaceuticals U.S.A.; January 27, 2016.