GASTRIC IMAGING AND pH TELEMETRY STUDY

Gastric Imaging and pH-telemetry result summary

•          Fosamax subjects on average (median) have a stomach pH below 3.0 within 1.8 minutes after dosing, whereas EX101 subjects on average (median) are maintained above pH 3.0 for 36.3 minutes.  This difference is highly statistically significant.

•          The acidified ALN exposure risk period (defined as pH below 3 until 50 % of the stomach contents are emptied) is 21 minutes for Fosamax, but there is no such risk period for EX101. This difference is highly statistically significant.

•          If the 30 minute end of fast time is taken as the end of the risk period, Fosamax subjects are at risk for 28 minutes, and again EX101 subjects are not at risk.  This difference is also highly statistically significant. 

Sample from Gastric imaging and pH telemetry study:

Quote from Prof Clive Wilson:(J.P. Todd Professor of Pharmaceutics at University of Strathclyde, Scotland)

 “The elevation in pH reduces the irritant potential in the esophagus by two mechanisms. First the presentation of the alendronate in a pleasant effervescent liquid form reduces the concentration of agent in the esophagus compared to a tablet. In patients who have consistent poor clearance of tablets, this represents a risk factor for ulceration. The putative second mechanism, the reflux of alendronate under acid conditions should also be negated.”