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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%).
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