February 8, 2011 by staff
Gabapentin, Depomed, Inc. (NASDAQ: DEPO) announced today that its phase 1 of the second pharmacokinetic-pharmacodynamic study in patients with Parkinson’s, MD-1992, Depomed’s novel investigation of the stomach retention, the sustained release formulation of levodopa / carbidopa, has maintained therapeutic blood levels of levodopa for 24 hours in a twice-daily formulation.
Two separate formulations twice daily DM-1992 was tested in the study. Both formulations are projected at steady state to always maintain levodopa blood levels above the threshold of 300 ng / ml for 24 hours effective, as the average blood levels of levodopa after 24 hours exceeds 300 ng / ml. DM-1992 was well tolerated in the study.
“We believe that DM-1992 can meet a significant unmet need of patients with Parkinson’s for a twice-daily formulation of levodopa / carbidopa who maintains therapeutic blood levels throughout the night, when the symptoms of Parkinson’s disease can be particularly serious, “said Carl Pelzel, Depomed President and CEO. “We are eager to discuss development of DM-1992 with potential partners for collaboration,” said Pelzel.
“We are pleased that our reformulation of DM-1992 realized that we expected patients with Parkinson’s. We believe we have produced candidate ready to move into Phase 2 clinical trials, “said Dr. Mike Sweeney, vice president of research and development of Depomed.” We thank the Foundation Michael J. Fox for his support to finance part of the trial, “said Sweeney.
The company plans to present the test results at a scientific conference later this year.
Phase 1 trial
DM-1992 is a novel investigation of gastric retention, sustained release dosage form of levodopa / carbidopa treatment on the market used in the treatment of Parkinson’s disease. The phase I trial in DM-1992 was a randomized, open window, we recruited 16 patients with stable Parkinson’s disease in two neurology centers leader in Russia. The aim of the study was to compare the pharmacokinetics-pharmacodynamics of two separate formulations twice daily DM-1992 and a generic version of Sinemet CR extended-release levodopa / carbidopa administered three times a day, and the safety and Tolerability of the formulations. Patients in the trial received a dose of one full day of the three study treatments (two doses of each DM-1992 (460 mg levodopa and carbidopa with 150 mg per dose) twelve hours of interval, and three doses of levodopa generic / carbidopa during 1:12 period (200 mg levodopa and carbidopa 50mg per dose). Blood samples were taken and finger tapping was determined during the period 24 hours after administration of each treatment.
About Parkinson’s disease
Parkinson’s disease is a chronic, degenerative neurological disease that affects nearly one million Americans, with strong growth expected in prevalence over the next 25 years due to demographic aging. Six million worldwide are estimated to have Parkinson’s disease. Although the average age of onset is 60, disease onset starts at age 40 in about five to 10 per cent of patients, and people as young as 30 can also be affected. Current treatments are effective in combating the mild / moderate motor symptoms of the disease and have long-term side effects. There are no drugs available that target many non-motor aspects of the disease and the underlying degenerative process.
About the Foundation Michael J. Fox for Parkinson’s Research (MJFF)
YWWF is dedicated to finding a cure for Parkinson’s disease through an aggressively funded research agenda and ensure the development of more effective treatments for people living with Parkinson’s today.
Depomed, Inc. is a specialty pharmaceutical company with an approved product on the market and has developed another product approved. Glumetza ® (metformin hydrochloride tablets extended release) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. GRALISE ™ (gabapentin) is a treatment administered once a day approved for the management of postherpetic neuralgia (PHN) and has been licensed to Abbott Products, Inc. The company also has a robust pipeline including one in Phase 3 clinical development, and other product candidates in its portfolio of early stage. Sereda ® product candidate is in phase 3 clinical development for menopausal hot flashes. Depomed makes its products and product candidates with proven, proprietary technology acuformis ® drug delivery, which aims to improve oral medications, allowing the controlled release of medications to the upper gastrointestinal tract when is dosed with food. Additional information about Depomed may be found on its website http://www.depomed.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995.
Statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, without limitation, those related to potential benefits of the DM-1992; possible operations of business development, our research and development and other risks detailed in the Company Securities and Exchange Commission, including the Annual Information Form 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 that 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 can be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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