Depomed, Inc. Announces Positive Top-Line Results from Phase 3 Clinical Trial of DM-1796 in Postherpetic Neuralgia
MENLO PARK, Calif.--(BUSINESS WIRE)--Oct. 5, 2009-- Depomed, Inc. (NASDAQ:DEPO) today announced top-line results from a Phase 3 clinical trial demonstrating DM-1796 (also referred to as gabapentin ER) achieved a statistically significant reduction in pain associated with postherpetic neuralgia (PHN) versus placebo using the baseline observation carried forward (BOCF) method required by FDA. The primary endpoint measured pain scores from baseline to the end of a ten-week treatment period using the numerical Likert pain scale.
DM-1796 is an investigational extended release, once-daily tablet formulation of gabapentin for the treatment of PHN. Depomed has licensed DM-1796 to Solvay Pharmaceuticals, Inc. in the United States, Canada and Mexico for the treatment of pain.
"This study demonstrates the effectiveness of our proprietary drug delivery technology in producing meaningful clinical benefits for PHN patients. We look forward to working with our strong and committed partner, Solvay Pharmaceuticals, through the regulatory process and making DM-1796 a commercial success," said Carl A. Pelzel, president and chief executive officer of Depomed.
"The study results represent another step forward in the potential for DM-1796 to be an important new option for patients with postherpetic neuralgia who often struggle to find effective pain relief treatments," noted Dr. Michael Sweeney, Depomed's vice president, Research and Development. "Gabapentin has proven efficacy, and the study data suggest that the new extended-release formulation may offer a favorable side effect profile and added convenience," Dr. Sweeney added.
Conducted by Depomed, the randomized, double-blind, placebo-controlled study involved 452 PHN patients. Patients in the study were randomized into two treatment arms: placebo or 1800 mg of DM-1796 dosed once-daily. Secondary objectives included an assessment of changes from baseline in sleep interference, and additional patient and clinician assessments of pain and quality of life. In the study, DM-1796 was well tolerated. The most common side effects observed in patients receiving DM-1796 were dizziness (11.3% compared to 1.7% for placebo) and somnolence (5.4% compared to 3.0% for placebo).
Full study results are being analyzed at this time and will be submitted for presentation at a future medical meeting. A New Drug Application (NDA) for DM-1796 for the treatment of PHN is expected to be submitted to the U.S. Food and Drug Administration (FDA) by the end of first quarter 2010.
Depomed will conduct a conference call and webcast today at 9 a.m. EDT to discuss the results from the trial. The conference call will be available via a live webcast on the investor relations section of Depomed's website at http://www.depomed.com. Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software. An archived webcast replay will be available on the Company's website for three months.
Postherpetic neuralgia (PHN), or pain after shingles, is a persistent neuropathic pain condition. It is caused by nerve damage after shingles, or herpes zoster, viral infection and afflicts approximately one in five patients diagnosed with shingles (~200,000 new cases each year) in the US1A,1B. The incidence of PHN increases in elderly patients -- 75 percent of shingles patients over 75 years old develop PHN. The pain associated with PHN can range from minor discomfort to very severe, preventing patients from taking part in normal daily activities2A.
DM-1796 is currently being studied as a once-daily treatment for postherpetic neuralgia in 300 and 600 mg strengths. It features a unique extended release formulation, which allows for the drug to be gradually absorbed into the blood. This reduces peak concentrations commonly seen with immediate release formulations currently on the market. A reduction in peak concentrations may result in a low incidence of side effects. Treatment tolerability and a convenient dosing regimen could potentially translate into greater patient compliance and ultimately better pain management.
Depomed, Inc. is a specialty pharmaceutical company with two product candidates in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline. Product candidate DM-1796 is in Phase 3 clinical development for the treatment of neuropathic pain and has been licensed to Solvay Pharmaceuticals. Product candidate SeradaTM is in Phase 3 clinical development for menopausal hot flashes. Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed 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. Additional information about Depomed may be found on its website, www.depomed.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to our clinical development program for DM-1796; potential benefits of DM-1796; 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; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and 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. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
1. Centers for Disease Control and Prevention: Shingles Disease - Questions and Answers. Available at: http://www.cdc.gov/vaccines/vpd-vac/shingles/dis-faqs.htm. Accessed: June 26, 2009
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2. National Pain Foundation: Postherpetic Neuralgia. Available at: http://www.nationalpainfoundation.org/articles/748/what-is-it?&PHPSESSID=ac487577644bb31ac68d1049f0da5e17. Accessed: June 26, 2009
a. Page 1, Paragraph 6
Source: Depomed, Inc.
Sheilah Serradell, 650-462-5900