(ARA) — Nearly 19 million Americans currently live with Gastroesophageal Reflux Disease (GERD), commonly known as acid reflux disease, and suffer from painful and uncomfortable symptoms such as frequent and persistent heartburn.
The Food and Drug Administration (FDA) recently approved KAPIDEX (TM) (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive GERD, the healing of erosive esophagitis (EE) and the maintenance of healed EE. KAPIDEX (30 mg and 60 mg) is the first PPI with a Dual Delayed Release (TM) (DDR) formulation that provides two separate releases of medication.
The Food and Drug Administration (FDA) recently approved KAPIDEX (TM) (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive GERD, the healing of erosive esophagitis (EE) and the maintenance of healed EE. KAPIDEX (30 mg and 60 mg) is the first PPI with a Dual Delayed Release (TM) (DDR) formulation that provides two separate releases of medication.
GERD is a chronic condition that can occur when the valve at the lower end of the esophagus does not work properly, causing stomach contents to back up into the esophagus repeatedly. If the esophagus is continually exposed to stomach contents, damage to the lining of the esophagus such as breaks or lesions can occur, a condition known as erosive esophagitis (EE).
GERD can affect both men and women, and its symptoms are often triggered by certain foods, stress, or pressure on the stomach.
“Clinical studies have shown that KAPIDEX has the ability to provide up to 24-hour heartburn relief in patients with GERD,” said Charles Baum, M.D., executive medical director at Takeda Pharmaceuticals North America, Inc. “KAPIDEX is the first PPI that provides two separate releases of medication.”
About KAPIDEX (dexlansoprazole) delayed release capsules
KAPIDEX (dexlansoprazole) delayed release capsules, previously known by the development code TAK-390MR, is a proton pump inhibitor (PPI), which decreases acid production by turning off many of the acid pumps in the stomach, thus helping to protect the esophagus from acidic reflux so that esophageal inflammation can heal. KAPIDEX combines an enantiomer of lansoprazole with a Dual Delayed Release (TM) (DDR) formulation designed to provide two separate releases of medication. KAPIDEX, taken once-daily, is approved for the healing of all grades of erosive esophagitis (EE) for up to eight weeks, maintaining healing of EE for up to six months, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.
Important Safety Information
KAPIDEX is contraindicated in patients with known hypersensitivity to any component of the formulation. Symptomatic response with KAPIDEX does not preclude the presence of gastric malignancy. The most commonly reported treatment-emergent adverse reactions (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. KAPIDEX should not be co-administered with atazanavir. KAPIDEX may interfere with the absorption of drugs for which gastric pH is important for bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole). Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time.
Please see the complete prescribing information and visit the KAPIDEX Web site at www.kapidex.com.
KAPIDEX is a product of Takeda Pharmaceuticals North America, Inc. To learn more about the product, speak with your healthcare provider.





