Navigation Links
Takeda's Investigational PPI TAK-390MR Demonstrated Higher Healing Rates Compared to Lansoprazole as the Severity of Erosive Esophagitis Grade Increased, a New Integrated Analysis Showed
Date:10/6/2008

TAK-390MR Data Presented at the American College of Gastroenterology Annual

Meeting

ORLANDO, Fla., Oct. 6 /PRNewswire/ -- 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(TM) (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(TM) (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 (greater than or equal to 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.

Abstract # P377


'/>"/>
SOURCE Takeda Pharmaceuticals North America, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
2. A Worldwide Phase III Clinical Trial Seeks U.S. Patients to Explore Investigational Drug Phenoxodiol
3. Ardea Biosciences, Inc. Announces Completion of Phase 1 Clinical Trials of Novel Investigational HIV Drug RDEA806
4. ECLIPSE Data on Effects of Otsukas Investigational Novel Treatment, Tolvaptan, on Advanced Heart Failure Patients Hemodynamics and Urine Output Featured in Heart Failure Society of Americas Late Breaking Trials
5. Replidynes Investigational Antibacterial Agent REP3123 Prevents Sporulation in Clostridium difficile
6. Replidynes Investigational Antibacterial Agent REP3123 Prevents Toxin Production in Clostridium difficile
7. Wyeth Presents Phase 3 Fracture Data for Bazedoxifene, an Investigational Therapy for Osteoporosis
8. Newly Published Phase II Study Shows the Investigational Drug Vandetanib Prolongs Progression-Free Survival in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
9. KineMed Presents Preclinical Data for Investigational Agent Demonstrating Neurogenesis and Confirming Improvements in Behavioral Model
10. Lexicon Reports Initial Clinical Trial Results for LX1031, an Investigational New Drug for Irritable Bowel Syndrome
11. Roches Investigational Polymerase Inhibitor, Combined with PEGASYS(R) and COPEGUS(TM), Shows Potent Antiviral Activity in Treatment of Chronic Hepatitis C at Four Weeks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/9/2017)... 9, 2017 Zimmer Biomet Holdings, Inc. (NYSE ... today announced it has earned a spot on ... The Company was ranked among 500 U.S. employers as ... Healthcare Equipment and Services. The annual ... anonymous, independent survey of over 30,000 employees across 25 ...
(Date:5/9/2017)... 2017  Semler Scientific, Inc. (OTCQB: SMLR), an ... improve the clinical effectiveness and efficiency of healthcare ... quarter ended March 31, 2017. ... to identify when preventive care options are appropriate, ... heart attacks or strokes occur," said Doug ...
(Date:5/6/2017)... , May 5, 2017   Provista , a proven ... than 200,000 customers, today announced Jim Cunniff as ... of executive and business experience to Provista, including most recently ... in California . He assumed his new ... is a great fit for Provista," says Jody Hatcher ...
Breaking Medicine Technology:
(Date:5/26/2017)... ... 2017 , ... After raising nearly $30,000 on Kickstarter , about three-times ... at a discounted crowdfunding price on Indiegogo . , “Along with creating an ... to bring a fidget toy to the market that was made of superior quality ...
(Date:5/26/2017)... ... May 26, 2017 , ... “When the Stars Lead Home”: a poignant ... of published author Laura Weigel Douglas, an avid reader who lives in the Pacific ... sometimes feels like Green Hills Adventure Camp. She couldn’t be more grateful. , Twelve-year ...
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... Water damage ... Lee, New Jersey School District had left education officials with a number of critical ... replacement of the flooring had to be accomplished with little or no disruption to ...
(Date:5/24/2017)... ... 24, 2017 , ... NucleusHealth ™, advancing clinical practice ... Food and Drug Administration (FDA) 510(k) clearance for its Nucleus.io ... for medical image management. At the core is patented streaming technology that provides ...
(Date:5/24/2017)... ... May 24, 2017 , ... Myers Jackson is well ... the ability to sell luxury homes anywhere on the planet. The luxury home market ... from Hattiesburg to Houston city-scapes. A quick search of “11 Spyglass Hill Auction will ...
Breaking Medicine News(10 mins):