TAK-390MR Demonstrated Higher Healing Rates Compared To Lansoprazole As The Severity Of Erosive Esophagitis Grade Increased

Main Category: Acid Reflux / GERD
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 07 Oct 2008 - 1:00 PDT

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Combined results from two Phase 3 studies presented at the American College of Gastroenterology Annual Scientific Meeting (ACG) in Orlando, Fla., demonstrated that TAK-390MR resulted in higher healing rates than lansoprazole among patients with more severe grades of erosive esophagitis (EE). TAK-390MR combines dexlansoprazole with a Dual Delayed Release™ (DDR) formulation, designed to provide two separate releases of drug for extended duration of acid suppression.

"These data are encouraging, as they suggest that TAK-390MR may provide an innovative new treatment option for patients with GERD, including those with more severe grades of erosive esophagitis," said David Peura, M.D., professor of medicine, University of Virginia Health System.

As part of the Phase 3 clinical trials, 4,092 patients were assessed for overall EE healing at week eight in two identically designed trials. Patients were randomized to receive 60 mg or 90 mg of TAK-390MR or 30 mg of lansoprazole. A retrospective, integrated analysis showed the difference in healing rates, or therapeutic gains, between 60 mg and 90 mg of TAK-390MR and 30 mg of lansoprazole, increased as the severity of EE increased. Therapeutic gains were greatest in patients with the most severe grade of EE (grade D): 12 percent for 60 mg (n=74) and 20 percent for 90 mg (n=83) of TAK-390MR. There were no significant differences in adverse events observed between the treatment groups.

"The development of TAK-390MR is another example of Takeda's commitment to patients who suffer from GERD and erosive esophagitis," said Dr. Stuart Atkinson, vice president of clinical science at Takeda. "TAK-390MR has the potential to serve as an important new treatment option for physicians and patients. If approved, it would be the first PPI that employs a dual delayed release formulation, delivering medication in two separate releases."

Additional TAK-390MR data being presented at ACG includes:

-- Long-Term Safety of TAK-390MR, a PPI with a Novel Dual Delayed Release Formulation, in GERD Patients.

Abstract P391, Poster Presentation, Monday, October 6

-- Placebo-Controlled Trial of Two Doses of TAK-390MR, a PPI with Novel Dual Delayed Release Technology, as Maintenance Treatment for Patients with Healed Erosive Esophagitis (EE). Abstract P21, Poster Presentation, Sunday, October 5

-- TAK-390MR Maintains Relief of Gastroesophageal Reflux Disease (GERD) Symptoms and Improvements in Quality of Life in GERD Patients with Healed Erosive Esophagitis. Abstract P24, Poster Presentation, Sunday October 5

-- TAK-390MR, a Novel Dual Delayed Release Formulation of a PPI, is Bioequivalent When Administered as Granules Sprinkled Over Applesauce or as an Intact Capsule. Abstract P394, Poster, Monday, October 6

About TAK-390MR

TAK-390MR, an investigational compound, is currently under review with the U.S. Food and Drug Administration (FDA) for once-daily, oral treatment of daytime and nighttime heartburn and other symptoms of Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis and the maintenance of healed erosive esophagitis. TAK-390MR combines an enantiomer of lansoprazole with a Dual Delayed Release™ (DDR) formulation designed to provide two separate releases of drug for extended duration of acid suppression. The New Drug Application for TAK-390MR was based on global studies conducted in 20 countries, in approximately 6,000 patients with erosive and non-erosive GERD. The most commonly reported treatment-related adverse reactions (≥ 1%) in Phase 3 clinical trials were diarrhea (3.6%), abdominal pain (2.1%) and flatulence (1.1%).

About GERD and EE

GERD affects nearly 19 million Americans and is often characterized by frequent and persistent heartburn that occurs two or more days a week. GERD can affect both men and women, and symptoms are often triggered by certain foods, stress or pressure on the stomach.

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 close 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 allow stomach contents to enter the esophagus repeatedly. The stomach is better equipped to handle acid than the esophagus. If the esophagus is continually exposed to stomach contents, damage to the lining of the esophagus can occur, resulting in breaks or lesions, a condition known as erosive esophagitis (EE

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, oncology, gastroenterology, neurology, rheumatology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about these Takeda companies, visit http://www.tpna.com.

Takeda Pharmaceuticals North America
http://www.tpna.com