Melt-in-Your-Mouth PPI for GERD Approved

The FDA today approved a new formulation of Takeda Pharmaceuticals' dexlansoprazole.

The FDA today approved a new formulation of Takeda Pharmaceuticals’ dexlansoprazole (Dexilant SoluTab).

Dexilant SoluTab, which can be used to treat heartburn associated with gastroesophageal reflux disease (GERD), is a delayed-release product that melts in patients’ mouths.

In addition to treating heartburn associated with GERD, the proton pump inhibitor (PPI) can be used for maintenance of healed erosive esophagitis and heartburn in adults aged 18 years and older.

Dexilant SoluTab’s dual delayed release technology offers 2 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," said Thomas Gibbs, senior vice president, General Medicines, Takeda, in a press release. "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."

Pharmacists can advise patients that the PPI should be taken at least 30 minutes before a meal. Patients should also not break or cut the tablets. Instead, patients should let the tablet melt without water or chewing. However, it can also be swallowed whole with water.

Patients should also avoid drinking alcohol when using the product.

Pharmacists may also inform patients that PPIs may be linked with Clostridium difficile-associated diarrhea. In addition, osteoporosis-related fractures of the hip, wrist, or spine may occur if patients use PPIs long-term on a multiple daily basis.

Adverse events may also include abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence.

The product had been available as a capsule for nearly 7 years, and there have been more than 25 million prescriptions filled for the product, according to a Takeda press release.