MENLO PARK, Calif., Jan. 24, 2012 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO) today announced that it has initiated a Phase 2 clinical trial of DM-1992, Depomed's novel gastric-retentive, extended-release formulation of carbidopa/levodopa, in patients with advanced Parkinson's disease with motor fluctuations.
"We believe DM-1992 may meet a significant unmet need of Parkinson's patients. DM-1992 is intended to be dosed twice-daily and to maintain consistent therapeutic blood levels of carbidopa/levodopa throughout the full 24 hour period and reduce the off/on fluctuations which occur with existing levodopa therapies and are so troublesome to Parkinson's disease patients," said Michael Sweeney, MD, Depomed's Chief Medical Officer and Vice President, Research and Development.
"Carbidopa/levodopa (CD/LD) is still considered the gold standard for treatment of Parkinson's disease," said Leo Verhagen, MD, PhD, a Parkinson's disease expert at Rush University Medical Center in Chicago, "but as the years go by, the duration of the benefit from each dose of CD/LD becomes progressively shorter. As a result, patients will take this medication many times (in some cases up to 10 times) per day. Even then they will still experience acute fluctuations between short periods of good mobility ("on" time) and episodes of immobility ("off" time). Therefore, having a CD/LD product that could provide more consistent blood levels for a longer period of time would represent an exciting addition to our current treatment options."
Phase 2 Trial Design
DM-1992 is an investigative novel gastric-retentive, extended-release dosage form of carbidopa/levodopa, a marketed therapy used in the treatment of Parkinson's disease. The Phase 2 clinical trial is designed to enroll at 8 U.S. clinical centers up to 45 patients with Parkinson's disease with motor fluctuations. The trial is a randomized, active-controlled, open-label, crossover study and will test DM-1992 dosed twice daily against a generic version of immediate-release carbidopa/levodopa dosed as needed. The study will assess efficacy, safety and pharmacokinetic variables. The primary endpoint for the study is change in off time as measured by patient self-assessment and clinician assessment.
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 people 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 approved and marketed products. GraliseTM (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized 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 release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
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"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 the potential benefits of DM-1992; our research and development efforts; 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. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. The achievement of those plans and objectives involves risks and uncertainties including, but not limited to, risks and uncertainties related to the timing and outcome of clinical trials, launch and market acceptance of Gralise; 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.