Depomed Announces Positive Results of Phase 2a Proof-of-Concept GERD Study
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."
Gastroesophageal reflux disease, also commonly referred to as GERD or acid reflux, is a condition affecting approximately 60 million individuals in the United States. While some of the therapies provide effective daytime treatment, approximately 3 million of GERD patients treated with proton pump inhibitors (PPIs) continue to experience nighttime acid reflux associated with NAB. NAB is a decrease in the pH of the stomach below 4.0 for more than one hour during the overnight period, and is associated with nocturnal heartburn and complications associated with GERD. NAB patients are often awakened from sleep by the pain from acid reflux associated with NAB and must take medication during the night to resolve nighttime acid reflux often associated with NAB.
Depomed, Inc. is a specialty pharmaceutical company with two approved products on the market and other product candidates in its pipeline. The company utilizes its proven, proprietary AcuForm(TM) drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of AcuForm-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. GLUMETZA(TM) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is being marketed in the United States by King Pharmaceuticals and in Canada by Biovail Corporation. Proquin(R) XR (ciprofloxacin hydrochloride) extended release tablets are approved in the United States for the once-daily treatment of uncomplicated urinary tract infections and will be marketed in the United States within the urology specialty by Watson Pharmaceuticals. Product candidate Gabapentin GR(TM) is currently in clinical development for the treatment of two pain indications. A Phase 2 clinical trial of Gabapentin GR in menopausal hot flashes is also under way. Additional information about Depomed may be found on its web site, www.depomedinc.com.
Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. The inclusion of forward-looking statements, including those related to the results of our clinical studies in gastroesophegeal reflux disease program, and potential benefits of our formulation of omeprazole, should not be regarded as a representation that any of our plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation, risks and uncertainties related to: our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; our ability to successfully commercialize our products; the success of our collaborative arrangements with development and commercialization partners; and other risks detailed in our filings with the Securities and Exchange Commission filings, including our most recent Annual Report on Form 10-K and our most recent Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. We undertake no obligation to revise or update this release to reflect events or circumstances that occur after the date of this release.
John Hamilton, 650-462-5900
Chief Financial Officer
Posted: September 2007