MENLO PARK, Calif.--(BUSINESS WIRE)--Aug. 10, 2009--
Depomed, Inc. (NASDAQ:DEPO) today announced that in its Phase 1
pharmacokinetic study in Parkinson’s patients, DM-1992, Depomed’s
investigative novel gastric retentive extended-release formulation of
levodopa/carbidopa, extended coverage above levodopa’s efficacious
threshold and extended the time to peak levodopa concentration relative
to currently available sustained release levodopa/carbidopa formulations.
One of Depomed’s formulations in the study extended the median time
point at which levodopa blood levels exceeded the efficacious threshold
of 300 ng/mL to approximately nine hours, compared to approximately
seven hours for the generic version of Sinemet CR tested in the study.
The time to median peak levodopa blood levels in the study was extended
to four hours, compared to 2.8 hours for the comparator. DM-1992 was
well tolerated in the study.
“We are encouraged by the pharmacokinetic results observed in this
study, as they indicate that DM-1992 may optimize the absorption of
Levodopa in the duodenum, the area of the upper gastrointestinal tract
where Levodopa is preferentially absorbed. We have already begun work
refining our formulation to optimize how our Acuform technology operates
within stomachs of Parkinson’s patients, with a view to achieving a
formulation that may be dosed twice daily with consistent efficacy and
reduced side effects, which would represent a significant clinical
benefit to Parkinson’s patients,” said Dr. Mike Sweeney, vice president
research and development of Depomed. “After we complete further
formulation work, we anticipate doing another phase I trial to confirm
the performance of the formulation before out licensing the program,”
added Dr. Sweeney.
“Depomed’s technology was able to significantly extend the duration of
plasma levels of levodopa/carbidopa. The Phase 1 clinical data was very
encouraging and we look forward to further work to perfect this
formulation in the clinic,” added Dr. Igor Stolyarov MD, PhD, Doctor of
Medical Sciences, Professor at Institution of Russian Academy of
Sciences “Institute of Human Brain of RAS", one of the two principal
investigators in the study with Professor Sergey Illarioshkin from St
Petersburg.
DM-1992 Phase I Trial Design
DM-1992 is an investigative novel gastric retentive extended-release
dosage form of Levodopa/Carbidopa, a marketed therapy used in the
treatment of Parkinson’s disease. The Phase I trial in DM-1992 was a
randomized, open-label crossover study that enrolled 18 patients with
stable Parkinson’s disease at two leading neurology centers in Russia.
The objective of the study was to compare the pharmacokinetics of two
distinct formulations of DM-1992 and a generic version of Sinemet CR
sustained-release Levodopa/Carbidopa, as well as the safety and
tolerability of the formulations. Patients in the trial received a
single dose of each of the three treatments being studied. A dose of the
first treatment was administered at the beginning of the study, followed
by a dose of a second treatment after 7 to 14 days, and a dose of the
third treatment after another 7 to 14 days. Blood samples were drawn
during the 24 hour period following administration of each treatment.
Patients remained on any anti-Parkinson’s therapy other than
Levodopa/Carbidopa during the trial.
About Parkinson’s disease
Parkinson’s disease is a chronic, degenerative neurological disorder
that affects nearly one million Americans, with significant prevalence
growth expected over the next 25 years due to aging population
demographics. Six million worldwide are estimated to have Parkinson’s.
While the average age at onset is 60, disease onset starts by age 40 in
an estimated five to 10 percent of patients, and people as young as 30
can also be affected. Current therapies are effective in addressing only
the mild/moderate motor symptoms of the disease and have significant
long-term side effects. There are no drugs available that target the
numerous non-motor aspects of the disease as well as the underlying
degenerative process.
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.
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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 business strategy;
potential business development transactions; our research and
development efforts, including pre-clinical and clinical testing;
regulation by the FDA and other government agencies; the timing of
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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.
Source: Depomed, Inc.
Depomed, Inc.
Sheilah Serradell, 650-462-5900
sserradell@depomed.com
