Message #49 From:
NewsBot Date: December 12, 2006 04:30:00 AM
DEPO News Depomed Announces Strong Positive Phase II Trial Results for Once Daily Gabapentin GR(TM) to Treat Symptoms of Diabetic Peripheral Neuropathy
MENLO PARK, Calif.--(BUSINESS WIRE)--Depomed, Inc. (Nasdaq:DEPO) today announced statistically significant
efficacy benefits of its Gabapentin GR™
extended release tablets for the once daily treatment of pain in
patients with diabetic peripheral neuropathy (DPN), a nerve disorder
caused by diabetes.
The multicenter, double-blind, placebo-controlled Phase II clinical
trial involved 147 randomized patients with diabetic peripheral
neuropathy. Patients were randomized into one of three treatment groups:
3000 mg Gabapentin GR dosed once or twice daily or placebo. The primary
objective of the four-week study was to assess the efficacy of
Gabapentin GR in treating the pain associated with DPN.
Reductions in average daily pain scores from baseline to the end of
treatment based on the 11 point Likert pain scale were statistically
significant with once daily Gabapentin GR. Clinically significant
improvements in the pain score were observed with a mean change from
baseline to study end of –2.45 compared to –1.26
for placebo (p= 0.002). Although not statistically significantly
different for twice daily Gabapentin GR, there was pain improvement with
a reduction in mean daily pain score of –1.75
with Gabapentin GR compared to –1.26 with
placebo (p= 0.190). These data were calculated using a baseline
observation carried forward analysis, meaning that a zero percent
improvement was assigned to patients who did not complete the study.
The secondary endpoint analysis of responders, defined as patients with
at least a 50 percent reduction in pain at endpoint compared to
baseline, showed that both once and twice daily Gabapentin GR arms
reached statistical significance. The proportion of responders was 35
percent for once daily Gabapentin GR (p= 0.001), 26 percent for twice
daily Gabapentin GR (p= 0.015) and 8 percent for placebo.
“These results are impressive and position
Gabapentin GR favorably in efficacy, safety and dosing convenience
against existing therapeutic options which are dosed at least three
times per day,” said John W. Fara, Ph.D.,
chairman, president and chief executive officer of Depomed. “The
data strongly support once daily Gabapentin GR and indicate that twice
daily dosing may also be an option for patients. We are enthusiastic
about sharing these data with companies that have expressed an interest
in partnering Gabapentin GR with us and are encouraged to advance our
development program for DPN forward.”
Sherwyn Schwartz, M.D., clinical investigator in the trial and director,
Diabetes & Glandular Disease Research Associates of San Antonio, said, “The
pharmacodynamic properties of Gabapentin GR provide long lasting drug
exposure to help manage the pain. This is especially important with
Gabapentin GR given once daily with an evening meal as pain is generally
more pronounced in patients at night. Patients are being dosed at what
appears to be an optimal time with a controlled release formulation that
provides extended pain relief throughout the day.”
Sleep interference, another secondary endpoint, decreased with both once
and twice daily Gabapentin GR, with the once daily Gabapentin GR
reaching statistical significance. In the once daily arm, Sleep
Interference Scores were reduced by –2.70
compared to –1.65 with placebo (p=0.01).
There were no serious adverse events associated with Gabapentin GR. The
most common side effects observed were dizziness and somnolence, which
are commonly associated with gabapentin. The reported incidences were
17.0 percent and 12.8 percent for dizziness and somnolence respectively
for once daily Gabapentin GR and 12.2 percent and 4.1 percent,
respectively for twice daily Gabapentin GR. In each of the three
treatment groups, once and twice daily Gabapentin GR and placebo, there
were only two patients who discontinued the study due to adverse events.
Carl Pelzel, executive vice president and chief operating officer of
Depomed, added, “We attribute these strong
safety and efficacy results to our unique formulation of gabapentin
which is based on our AcuForm™ drug delivery
technology. In pharmacokinetic studies, we showed improved
bioavailability of our Gabapentin GR at higher doses with a greater
percentage of the administered dose reaching the blood stream compared
to immediate release gabapentin. Today’s
efficacy and safety data complement the pharmacokinetic data and show
that the high doses do indeed serve to reduce pain and, in our unique
formulation, are well tolerated in this Phase II clinical study.”
About Diabetic Peripheral Neuropathy
Diabetic neuropathy is a peripheral nerve disorder caused by diabetes.
Approximately 60 to 70 percent of the 20 million diabetics in the United
States have mild to severe forms of nervous system damage. After a
period of inadequate glycemic control, nerve damage may occur and may
lead to a number of health problems, including indigestion, diarrhea or
constipation, dizziness, bladder infections and impotence. DPN is often
associated with numbness, pain, or tingling in the feet or legs and may
lead to weakness in the muscles of the feet. Current treatment
approaches for DPN involve providing options for pain relief and
implementing glycemic control measures, including diet, exercise and
medication, to prevent further tissue damage by bringing blood sugar
levels under control.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company utilizing its
innovative AcuForm™ drug delivery technology
to develop novel oral products and improved, extended release
formulations of existing oral drugs. AcuForm-based products are designed
to provide once daily administration and reduced side effects, improving
patient convenience, compliance and pharmacokinetic profiles. ProQuin®
XR (ciprofloxacin hydrochloride) extended-release tablets have been
approved by the FDA for the once daily treatment of uncomplicated
urinary tract infections and are currently being marketed in the United
States. In addition, once daily GlumetzaTM
(metformin hydrochloride extended release tablets) has been approved for
use in adults with type 2 diabetes and is currently being marketed in
the United States and Canada. The company is conducting a Phase III
trial in postherpetic neuralgia and has completed a Phase II trial in
diabetic peripheral neuropathy with its product candidate, Gabapentin GR™.
Additional information about Depomed may be found at its web site, www.depomedinc.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 trial results and analysis, 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 its 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.
