Takeda Pharmaceuticals USA, Inc., (Takeda) announced that the United States (US) Food and Drug Administration (FDA) approved Dexilant SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient’s mouth. Dexilant SoluTab is a proton pump inhibitor (PPI) indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and the maintenance of healed erosive esophagitis (EE) and relief of heartburn in adults 18 years and older. Dexilant SoluTab is a PPI with dual delayed release (DDR) technology that is designed to provide two separate releases of medication.
“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,” explained Thomas Gibbs, senior vice president, general medicines, Takeda. “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.”
In addition to Dexilant SoluTab, Dexilant is also available as a capsule. The capsule is indicated for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease, the healing of erosive esophagitis (EE) and the maintenance of healed EE in adults. Since being approved by the FDA, Dexilant capsules have been available for nearly 7 years with over 25 million prescriptions filled.
GERD is a chronic condition commonly known as acid reflux disease. 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.
GERD affects about 20 per cent of the US population and is often characterized by frequent and persistent heartburn two or more days a week despite treatment and diet changes. Adults who have trouble swallowing pills may consider discussing an alternate formulation option, such as an orally disintegrating tablet, with their doctor.
Dexilant (dexlansoprazole) 30 mg and 60 mg delayed-release capsules are indicated for healing all grades of erosive esophagitis (EE) for up to 8 weeks, maintaining healing of EE and relief of heartburn for up to 6 months, treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.
Dexilant SoluTab (dexlansoprazole) 30 mg delayed-release orally disintegrating tablets are indicated for maintaining healing of EE and relief of heartburn for up to 6 months, treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.
Two 30 mg Dexilant SoluTab are not interchangeable with one 60 mg Dexilant capsule. Dexilant SoluTab should be taken at least 30 minutes before a meal.
Most commonly reported adverse reactions were diarrhea (4.8 per cent), abdominal pain (4.0 per cent), nausea (2.9 per cent), upper respiratory tract infection (1.9 per cent), vomiting (1.6 per cent), and flatulence (1.6 per cent).