Navigation Links
Labopharm provides update on U.S. regulatory process for once-daily Tramadol
Date:9/24/2007

Company Believes Robust Clinical Data Package Provided in NDA Demonstrates

Efficacy and Safety of Once-Daily Tramadol Formulation

LAVAL, QC, Sept. 24 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that is has requested a meeting with the U.S. Food and Drug Administration (FDA), regarding the Company's New Drug Application (NDA) for its once-daily formulation of tramadol. Based on additional analysis that Labopharm has performed, as well as further discussions with its regulatory advisors, the Company believes that it has demonstrated the efficacy and safety of its once-daily tramadol formulation.

Based on data from the Company's global clinical trial program submitted with the NDA, including a positive Phase III study conducted in accordance with a Special Protocol Assessment, Labopharm strongly believes that it has provided the FDA with more than adequate evidence of the efficacy and safety of its once-daily formulation of tramadol.

Should Labopharm and the Agency fail to mutually agree on a path forward toward final regulatory approval, or should the FDA not grant the meeting within the next 30 days, Labopharm plans to appeal the FDA's current decision through the Agency's Formal Dispute Resolution process.

Labopharm's NDA for once-daily tramadol included data from the Company's global clinical development program including six Phase III clinical studies and 12 pharmacokinetic studies. Combined, more than 2400 patients have been exposed to Labopharm's once-daily tramadol in clinical studies.

About the FDA's Formal Dispute Resolution Process

FDA regulations provide a mechanism for those seeking regulatory approval of a drug product through a New Drug Application (NDA) to obtain formal review of any Agency decision through a Formal Dispute Resolution process by raising the matter with the supervisor of the employee who made the decision. If the issue is not resolved at the primar
'/>"/>

SOURCE Labopharm Inc.
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine news :

1. Protein provides antioxidant protection to Neurons
2. Acupuncture provides relief
3. Micro-camera provides new breast imaging technique
4. Hormone therapy provides no heart benefit
5. MicroRNA provides new insight into birth defects
6. Drug Spironolactone Provides Renal And Cardioprotection In Diabetic Patients
7. Neurobiology Provides Answers To Block Memory-Related Drug Cravings
8. Cholesterol provides immunity against infection by certain parasites
9. John Hopkins CGHH program provides Global Health education
10. London Hospital Provides Specialized Care For Pregnant Women
11. Hope Lodges provides free stay to cancer patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/5/2008)...ert Pathologists Discuss the Latest Developments i...RTHFIELD, Ill., Sept. 5 /PRNewswire-USNewswire/ --...point. Molecular testing and the promise,of person...reated. Digital,slides and other imaging technolog...lege of American Pathologists is taking a leadersh...
(Date:9/5/2008)...hers explain how theoretical ,anti-cloak, could br...pt. 5 (HealthDay News) -- Just in case someone dev...cientists say they know how to uncloak the objects... Optics Express , certain materials underneath an ...o be seen again. , Researchers at Shanghai Jiao...
(Date:9/5/2008)...HINGTON, Sept. 5 /PRNewswire-USNewswire/ -- Speake...y in support of the aims of the "Stand,Up to Cance... "There is not a person in our country who has no...r kills 565,000 Americans annually, and each,year ...ricans must work,together to make eradicating the ...
(Date:9/5/2008)...HINGTON, Sept. 5 /PRNewswire-USNewswire/ -- U.S. c...r relief to Cuban victims of Hurricane,Gustav, whi...s., (http://www.PanAmericanRelief.org ), "Donatio...perately need,after this natural disaster," says M... Initiative at the Pan American Development Founda...
Breaking Medicine News(10 mins):Health News:Leaders in Pathology Meet in San Diego: Sept. 25 - 28, 2008 2Health News:Cuban Disaster Relief Donations Sought in the Wake of Hurricane Gustav 2
...ns of influenza activity 2-4 weeks in advance in t... // Though there are outbreaks of influenza any ti...e announced which would act as a caution to people...es like vaccination. In a prediction market, peopl...
..., also called magic mushrooms can effectively redu...OCD), according to a study// by University of Ariz...es like psilocybin, psilocin, or muscimol. The fir...approved) was outlawed in 1970, according to AP re...
...ntiretroviral treatment (HAART), people with HIV m...ncies and abnormalities. // In two different stud...n the Department of Public Health and Family Medic...cine, and colleagues examined the incidence of met...
...lood to the part of the brain affected is interrup...iously damaged or die, impairing local brain funct... of a stroke, new blood vessels begin to form, and...ns migrate long distances to the damaged area to a...
Other Medicine News:Health News:The Outbreak of Influenza is Now Predicted 2Health News:HIV Treatments Improve Health, but Nutritional Issues Remain 2Health News:HIV Treatments Improve Health, but Nutritional Issues Remain 3Health News:Cellular Cues Identified for Stroke Recovery 2
(Date:9/5/2008)...Newswire-FirstCall/ -- CEL-SCI Corporation,(Amex: ...atoid arthritis data,at the Marcus Evans conferenc...ted by Dr. Daniel Zimmerman, Senior Vice President...cate that CEL-SCI,s rheumatoid,arthritis vaccine C...amage,caused by rheumatoid arthritis in an animal ...
(Date:9/4/2008)...signation for the treatment of Acute Myeloid ...J., Sept. 4 /- Celator Pharmaceutical...stration (FDA) has granted orphan,drug designation...ection,for the treatment of Acute Myeloid Leukemia...t two randomized Phase 2,studies with CPX-351. The...
(Date:9/4/2008)...4 /- Southern Research Institute,toda... (NIH) has selected,the organization to participat...oduction Center Network (MLPCN). The MLPCN -- a co...ecular Libraries Program which is,designed to bene...the human,genome and validate future targets for d...
(Date:9/4/2008)...nt Identification for Targeted Therapies ... HUNTINGTON BEACH, Calif., and AMSTERDAM, Nethe...eader in molecular cancer diagnostics,today annou...c test that,allows physicians to quantitatively de... receptor (ER), progesterone receptor (PR) and Hum...
Breaking Medicine Technology:Data Suggest CEL-SCI's CEL-2000 Vaccine Prevents or Retards Permanent Damage of Rheumatoid Arthritis 2Data Suggest CEL-SCI's CEL-2000 Vaccine Prevents or Retards Permanent Damage of Rheumatoid Arthritis 3Data Suggest CEL-SCI's CEL-2000 Vaccine Prevents or Retards Permanent Damage of Rheumatoid Arthritis 4Celator Pharmaceuticals Receives Orphan Drug Designation for Anticancer Agent CPX-351 2Southern Research Institute Wins $14.7 Million NIH Award to Participate in Molecular Libraries Probe Production Center Network 2Southern Research Institute Wins $14.7 Million NIH Award to Participate in Molecular Libraries Probe Production Center Network 3Southern Research Institute Wins $14.7 Million NIH Award to Participate in Molecular Libraries Probe Production Center Network 4Agendia Launches TargetPrint(R) for Breast Cancer Patients 2Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 1Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 2Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 3Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 4Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 5Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 6Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 7Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 8Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 9Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 10Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 11Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 12Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 13Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 14Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 15Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 16Cardiac Science Reports Record Fourth Quarter and Full Year 2007 Results 13067 17Ben Barber Career Tech Academy Leaps Forward With Help From Methodist Mansfield 13062 1Ben Barber Career Tech Academy Leaps Forward With Help From Methodist Mansfield 13062 2Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 1Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 2Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 3Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 4Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 5Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 6Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 7Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 8Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 9Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 10Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 11Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 12Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 13Cepheid Reports Fourth Quarter and Full Year 2007 Results 3606 14Weill Cornell team identifies potential new drug targets against hormone dependent breast cancer 13061 1Weill Cornell team identifies potential new drug targets against hormone dependent breast cancer 13061 2Weill Cornell team identifies potential new drug targets against hormone dependent breast cancer 13061 3
...08, 2007,/PRNewswire-FirstCall/ --Eurand to presen...ety Annual,Meeting. ...pancreatic insufficiency (EPI) is a,deficiency of ...he pancreas that can result from a number , , ...pancreatitis, and , , pancreatic cancer , , ...
...n 8, 2007 - ProEthic,Pharmaceuticals, Inc., a priv... acquires, develops, licenses, and markets niche,p...se III study,data for PRO-513, the Company,s produ...es. The results were presented in two poster,prese...nnual,Scientific Meeting in Chicago by Richard B. ...
Other Medicine Technology:Eurand to Present Zentase Phase III Data 2Eurand to Present Zentase Phase III Data 3ProEthic Pharmaceuticals Presents Positive Data for PRO-513 at,American Headache Society Meeting 2ProEthic Pharmaceuticals Presents Positive Data for PRO-513 at,American Headache Society Meeting 3ProEthic Pharmaceuticals Presents Positive Data for PRO-513 at,American Headache Society Meeting 4
Non-Temperature Ablation Catheters
The Deltec Cozmo® insulin pump is small, about the size of a cell phone, and only weighs 3.3 ounces (w/ battery and full cartridge). Its ergonomic design fits comfortably in the palm of your han
The Kowa Non-Contact Tonometer KT-800 comes with a one year parts and labor warranty.
...us perimetry, the visual field is examined with an...verlapping the ocular fundus image and the perimet...n the two., ,The data integrates with Kowa VK2...lly manage the fundus images and perimetry results...
Medicine Products: