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news.Sweden-based Orexo has said that new clinical data from a Phase II study confirms the competitive profile of Orexo's product OX17 in gastroesofageal reflux disease patients, which is fast, effective and sustained inhibition of gastric acid production, a prerequisite for effective symptom relief in the patient.
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In a controlled clinical trial with 59 gastroesofageal reflux disease (GERD) patients treated for 14 days, the anti-secretory effect of OX17 was compared to omeprazole and famotidine. The primary endpoint was fulfilled: OX17 significantly reduced the acid production compared to omeprazole day one. The time with pH>4 the first 12 hours after dosing was on average 60% longer with OX17 compared to omeprazole (p<0.05). After 14 days treatment, the time with gastric pH above four was twice as long as after treatment with famotidine. The patients' need for rescue medication (antacids) during the 14-day study period was considerably lower for OX17 compared to both famotidine and omeprazole indicating good control of GERD symptoms. Torbjorn Bjerke, president and CEO of Orexo, said: "The results confirm that OX17 has a favorable and unique clinical profile for a drug intended for the treatment of GERD. This is an important strategic step in our OX17-project, which further increases the project's commercial value. In 2006, the combined market for H2 receptor antagonists and proton pump inhibitors amounted to some $27 billion."