Sep 5 2007, 7:00 AM EST
News source: Business Wire
Depomed, Inc. (NASDAQ: DEPO) today announced the results of its recently completed Phase 2a pharmacokinetic / pharmacodynamic proof-of-concept study in gastroesophageal reflux disease (GERD). The study demonstrated the potential clinical advantages of the delivery of omeprazole in two evening pulses to patients suffering with nocturnal acid breakthrough (NAB) associated with GERD. Omeprazole, a proton pump inhibitor, is an FDA-approved compound for the treatment of GERD.
The objective of the study was to determine if the delivery of a dose of omeprazole with dinner and a second dose four hours after dinner would reduce the incidence of NAB, which typically occurs in the late evening and early morning hours. The study was an open label crossover study that involved 16 patients with at least three months history of GERD with recurrent nighttime acid reflux while taking omeprazole or any other proton pump inhibitor. Fourteen of the 16 patients completed each of two treatment arms. In the proof-of-concept arm of the study, patients received 20 mg of omeprazole with dinner followed by a second 20 mg dose four hours later, in order to simulate a two pulse delivery mechanism. In the comparative arm of the study, patients received 40 mg of omeprazole 30 minutes before dinner.
Five patients who received the two pulses of omeprazole did not have clinically meaningful blood levels of the drug associated with the first pulse and therefore did not provide useful data for this trial, because the study objective was to evaluate a two pulse delivery of the drug. These patients received the commercially available formulation of omeprazole known as Prilosec(R). It is not known why these patients did not achieve blood levels with Prilosec. However, this formulation is intended to be dosed prior to the meal.
In the nine patients who did achieve blood levels from both doses of omeprazole, and thus provided useful data for the two pulse concept tested in the trial, none experienced NAB. In the 40 mg single dose treatment arm, three patients experienced NAB. All three of these patients had blood levels of omeprazole fall to undetectable levels between 2 a.m. and 3 a.m.. Results from both arms of the study therefore demonstrate the need to maintain adequate blood levels of omeprazole in order to inhibit NAB.
In a previously completed GERD study, Depomed determined that its gastric retentive formulation of S-enantiomer of omeprazole can predictably deliver omeprazole approximately four hours after ingestion.
"Nighttime reflux associated with nocturnal acid breakthrough remains a real challenge for the nearly 15 million individuals diagnosed with chronic gastroesophageal reflux disease," said Lauren Gerson, M.D., Associate Professor of Medicine, Gastroenterology and Hepatology at Stanford University School of Medicine. "While additional research is needed, the two pulse delivery of omeprazole being evaluated by Depomed in this Phase 2a study is quite encouraging and warrants further evaluation."
Carl Pelzel, president and chief executive officer of Depomed said, "The critical finding in this study is that delivery of two evening pulses of 20 mg of omeprazole may satisfy a high unmet medical need. With the data from this study and our prior GERD study, we feel that we have completed our proof of concept work. As we open discussions with potential partners for this program, we plan to move on to dosing optimization to ensure absorption of both evening doses and further formulation based on our proprietary delivery approach. Interestingly, we believe that our findings in this study should be applicable to other proton pump inhibitors as well."
About GERD
Gastroesophageal reflux disease, also commonly referred to as GERD or acid reflux, is a condition affecting approximate
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