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news.Tap Pharmaceutical Products has reported promising results from three pivotal Phase III studies evaluating investigational new drug TAK-390MR, the first proton pump inhibitor with a dual delayed release technology, in healing patients with erosive esophagitis and in maintenance of healed EE.
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Data from the two separate erosive esophagitis (EE) healing studies demonstrated that patients treated with TAK-390MR 60mg and 90mg experienced higher overall healing after eight weeks compared to patients taking lansoprazole 30mg. In addition, data from six-month maintenance of healed EE study demonstrated that patients treated with TAK-390MR 30mg and 60mg experienced statistically significant overall maintenance and symptom relief over placebo.
TAK-390MR also demonstrated heartburn relief rates during the six-month trial. Patients treated with TAK-390MR were heartburn free a median of 99 and 96% of nights (30mg and 60mg respectively) compared to 71% of nights for patients treated with placebo. In addition, patients treated with TAK-390MR were heartburn free a median 96 and 91% of 24-hour days (30mg and 60mg, respectively) compared to 29% of 24-hour days for patients treated with placebo.
David Metz, professor of medicine at University of Pennsylvania School of Medicine, said: “The heartburn relief rates are encouraging, particularly when you consider that they reflect symptom relief during the complete 24-hour period. These maintenance results coupled with the overall healing results are encouraging for the potential of TAK-390MR in treating patients with gastroesophageal reflux disease.”