Depomed, Inc. Announces Positive Top-Line Results from Phase 3 Clinical Trial of DM-1796 in Postherpetic Neuralgia

* Reuters is not responsible for the content in this press release.

Mon Oct 5, 2009 7:00am EDT

MENLO PARK, Calif.--(Business Wire)--
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

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. 

About DM-1796

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. 

About Depomed

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. 

References

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 

a. Page 2, Paragraph 1 

b. Page 2, Paragraph 2 

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

Depomed, Inc.
Sheilah Serradell, 650-462-5900
sserradell@depomed.com



Copyright Business Wire 2009

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