Navigation Links
Depomed Reports Top Line Data for Phase 2 Study in Parkinson's Disease
Date:11/7/2012

MENLO PARK, Calif., Nov. 7, 2012 /PRNewswire/ -- Depomed, Inc. (Nasdaq: DEPO) today announced top line results from a Phase 2 clinical trial of DM-1992, Depomed's investigative novel gastric-retentive, extended-release formulation of carbidopa/levodopa, in patients with advanced Parkinson's disease with motor fluctuations.

Phase 2 Study Design and Results
The trial was a randomized, active-controlled, open-label, crossover study evaluating DM-1992 dosed twice daily against a generic version of immediate-release carbidopa/levodopa (IR CD/LD) dosed as needed (mean daily dosing frequency = 4.8). 34 patients with advanced Parkinson's disease with motor fluctuations enrolled in the study at eight U.S. clinical centers. All enrolled patients completed the study.

Baseline measurements were established over a three-day patient self-assessment period during which patients were maintained on existing Parkinson's medications. DM-1992 and IR CD/LD were each administered over a ten-day period that included a six-day dose optimization period, followed by a three-day patient self-assessment period and one in-clinic day for clinician evaluation and pharmacokinetic measurements.

The primary endpoint for the study is change in percent "off" time during waking hours, as measured by patient self-assessment during the treatment period relative to the baseline period. Patients' mean baseline "off" time during waking hours was 5.4 hours per day (32.5%), compared to 4.5 hours (27.2%) during the DM-1992 self-assessment period and 5.5 hours (33.5%) for the IR CD/LD comparator. The reduction in percent "off" time reported during the DM-1992 patient self-assessment period relative to the IR CD/LD comparator was statistically significant (p = 0.047).

Patients who experienced an "off" state for more than two hours were permitted to take IR CD/LD as rescue medication. Patients took 1.3 mean daily doses of rescue medication during the DM-1992 patient self-assessment period, compared to 0.2 mean daily doses for the IR CD/LD comparator.

DM-1992 was generally well tolerated in the study. There were no serious adverse events.

"We will continue to evaluate these data, as we consider partnering opportunities for DM-1992 and monitor competitive developments," said James Schoeneck, Depomed's President and CEO.

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 three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. 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.

"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 development programs and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2011 and the Quarterly Reports on Form 10-Q for the quarter ended September 30, 2012.  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. 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.

CONTACT:
August J. Moretti
Depomed, Inc.
650-462-5900
amoretti@depomed.com


'/>"/>
SOURCE Depomed, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Depomed Announces Receipt of $1 million Milestone Payment From Ironwood Pharmaceuticals, Inc.
2. Depomed To Present At Jefferies 2012 Global Health Care Conference
3. Depomed Announces Filing Of Shelf Registration To Replace Existing Shelf
4. Depomed To Present At JMP Securities 7th Annual Healthcare Conference
5. Depomed To Report Second Quarter Fiscal Year 2012 Financial Results On Thursday, August 2, 2012
6. Depomed To Present At Stifel Nicolaus 2012 Healthcare Conference
7. Depomed To Present At Morgan Stanley 2012 Healthcare Conference
8. Depomed To Present At UBS Global Life Sciences Conference
9. Depomed To Report Third Quarter Fiscal Year 2012 Financial Results On Monday, November 5, 2012
10. Depomed Reports Third Quarter Financial Results
11. Depomed To Present At Lazard 2012 Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... Conference Call and Webcast to Follow Vanda Pharmaceuticals Inc. ... results for the fourth quarter of 2016 on Wednesday, February 15, ... ... PM ET on Wednesday, February 15, 2017, during which management will ... other corporate activities. To participate in the conference call, please dial ...
(Date:1/19/2017)... , Jan. 19, 2017  Stealth BioTherapeutics Inc. ( ... treat mitochondrial dysfunction, today announced new additions to its ... as Chief Medical Officer, and Daniel Geffken ... that Jim Carr , Pharm.D. has been promoted ... are pleased to welcome Doug and Daniel to our ...
(Date:1/19/2017)... 2017  Abaxis, Inc. (NasdaqGS: ABAX ), ... and consumables for the medical and veterinary markets worldwide, ... results for the third quarter fiscal year 2017, ended ... p.m. ET on Thursday, January 26, 2017.  The Company ... year 2017 after the market closes on Thursday, January ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... 2017 , ... “Mary Magdalene: Grace is Greater than Sin”: a unique ... Jesus Christ firsthand. “Mary Magdalene: Grace is Greater than Sin” is the creation of ... interacting with countless women who had little knowledge of the female characters portrayed in ...
(Date:1/20/2017)... ... January 20, 2017 , ... ... Oscillating Positive Expiratory Pressure (OPEP) device, was featured in a study indicating superior ... MEd, RRT-ACCS, FAARC, “Analysis of Three Oscillating Positive Expiratory Pressure Devices During ...
(Date:1/20/2017)... ... January 20, 2017 , ... “The Land of More and More”: ... of world hunger, and shares the simple and achievable answer. “The Land of More ... of the Fairview Missionary Church in Angola, Indiana where he works with the children’s ...
(Date:1/19/2017)... ... 19, 2017 , ... Next week after January 20th, the fear for many ... that circumvent health needs of over 30 million. Many interviews with Dr. Carol Francis ... government public servants were suppose to prioritize. Interviews provided below. , Among ...
(Date:1/19/2017)... ... January 19, 2017 , ... ... and scientists from around the world, announces the launch of its newly redesigned ... easy portal to research breakthroughs and trending news, vital information on upcoming virtual ...
Breaking Medicine News(10 mins):