Depomed Announces Initiation of Phase 2 Clinical Study in Parkinson's Disease
GlobeNewswirePress Release: Depomed, Inc. – 2
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MENLO PARK, Calif., Jan. 24, 2012 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO - News) 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.
