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