Navigation Links
SCOLR Pharma, Inc. Announces Positive Top-Line Results From Pivotal Clinical Trial Evaluating Efficacy of Extended-Release Ibuprofen
Date:11/6/2008

Pivotal Phase III Trial Primary Endpoints Achieved for SCOLR's 12 Hour Ibuprofen

BOTHELL, Wash., Nov. 6 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD) today reported favorable top-line results from its pivotal Phase III trial to evaluate the safety and efficacy of its 12 hour CDT(R) 600 mg. extended-release (ER) ibuprofen for the over-the-counter (OTC) market. The trial incorporated FDA special protocol assessment design elements, met both co-primary endpoints (p<0.0001), and had no significant adverse events.

As previously reported, the Company successfully completed two Phase III trials comparing the blood levels of its 12 hour extended-release ibuprofen to three 200 mg Motrin(R) (immediate-release reference standard) tablets. In the current pivotal Phase III efficacy study performed at a single center in the United States, of the 306 patients screened, 256 patients received study medication. This randomized, placebo-controlled, double-blind, parallel group study was designed to evaluate the efficacy and safety of multiple doses of ibuprofen 600 mg ER in dental pain following third molar extraction. The first primary endpoint was to demonstrate analgesic efficacy for the 8-12 hour period after the first dose of SCOLR's ER ibuprofen as compared to placebo. The second primary endpoint measured the durability of effect of SCOLR's formulation by the proportion of subjects in the ibuprofen ER group with meaningful improvement in pain intensity from baseline at all three assessment periods of 24, 36, and 48 hours. Both endpoints achieved positive, statistically significant results, at the p<0.0001 level.

Stephen Turner, the Company's Chief Technical Officer, commented, "We are extremely pleased with these critica
'/>"/>

SOURCE SCOLR Pharma, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. SCOLR Pharma, Inc. Schedules Third Quarter 2008 Financial Results Conference Call for November 7, 2008 at 11:30 A.M. Eastern
2. SCOLR Pharma, Inc. Submits Abbreviated New Drug Application for a 12-hour CDT-based Pseudoephedrine Formulation
3. Why Do Drugs Cost So Much? and why are we so darn sick?: New Book Reveals Inner Workings of Big Pharma, Asks Hard Questions About Our Health
4. Galderma Pharma, S.A. and ZARS Pharma, Inc. Extend Agreement to Cover Worldwide Rights for Pliaglis(TM)
5. Legislative and Regulatory Outlook - 2009 and Beyond for Pharma, Biotech Players
6. TyRx Pharma, Inc. Announces Presentation of Results to Benefit Women with Breast Implants (In-Vivo Efficacy Study Regarding AIGISRx DEB) at the Plastic Surgery 2007 Meeting on October, 28 2007 in Baltimore, MD
7. GeoPharma, Inc. to Present at the EdgeWater Research Investor Conference
8. CutisPharma Announces Issuance of a Patent for Suppository Compounding
9. Stereotaxis Announces New Management Appointment
10. SXC Health Solutions announces third quarter financial results
11. 360 Healthcare Staffing Announces Agreement With BlueSky Medical Staffing Software
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... (PRWEB) September 30, 2014 The ... to improve breast cancer risk prediction and to ... a study published in Breast Cancer Research (BCR ... density and breast cancer risk: a case-control study ... strong connection between breast density and breast cancer ...
(Date:9/30/2014)... partners successfully established a visual mapping of the ... suppressor cells (MDSC). The damage and immune suppression ... this is a major stepping stone in creating ... factors from precursors present in hematopoietic organs such ... population of cells suppresses the activity of various ...
(Date:9/30/2014)... University of Eastern Finland shows that dietary polyunsaturated fatty ... The sources of polyunsaturated fatty acids include fish, vegetable ... Arteriosclerosis, Thrombosis & Vascular Biology , an esteemed journal ... not found an association between the consumption of saturated ... that the mere reduction of saturated fats from the ...
(Date:9/30/2014)... This two-day, advanced PT continuing education course ... may arise following a concussion or mild traumatic brain ... from sports related injuries, car accidents, falls, to the ... of returning soldiers from war zone regions. While at ... can result in similar injuries, the course will emphasize ...
(Date:9/30/2014)... By Dennis Thompson ... -- Every day, people receive medical implants -- artificial ... may not have been rigorously tested before or after their ... studies contend. The studies -- conducted by prominent nonprofit ... Medicine -- lay the blame for inadequate medical device ...
Breaking Medicine News(10 mins):Health News:Mammographic Density Offers Potential to Improve Prediction of Breast Cancer Risk and Development of Personalized Screening 2Health News:Mammographic Density Offers Potential to Improve Prediction of Breast Cancer Risk and Development of Personalized Screening 3Health News:Mammographic Density Offers Potential to Improve Prediction of Breast Cancer Risk and Development of Personalized Screening 4Health News:Dietary polyunsaturated fatty acids linked to smaller risk of coronary heart disease 2Health News:North American Seminars Presents Traumatic Brain Injury and Concussions in Conduction with St. Anthony's Medical Center in St. Louis, MO on November 8-9, 2014 2Health News:North American Seminars Presents Traumatic Brain Injury and Concussions in Conduction with St. Anthony's Medical Center in St. Louis, MO on November 8-9, 2014 3Health News:Medical Implant Devices Skate Through Review Process, Studies Claim 2Health News:Medical Implant Devices Skate Through Review Process, Studies Claim 3Health News:Medical Implant Devices Skate Through Review Process, Studies Claim 4
... these patients, researcher says , , FRIDAY, Oct. 10 (HealthDay ... 75 percent higher risk for developing colorectal cancer sometime ... syndrome is a conglomeration of three or four diseases, ... illnesses, including a number of cancers," said study co-author ...
... excellence in the implementation of electronic health records (EHRs), the ... of the 2008 Davies Awards in the Organizational, Ambulatory and ... ... Chicago, IL (PRWEB) October 10, 2008 -- Honoring excellence in ...
... Mich.---The University of Michigan received $5 million from the ... resource of high-quality experimental data sets of drug-making compounds ... new level. , The resource will house the ... the effectiveness of potential new drugs, said Heather Carlson, ...
... 10 The Johns Hopkins University School,of Medicine ... Breast Cancer Strategies: From Biomarkers to Treatment,Selection," to ... advances in,breast cancer treatment., In recent years, ... to chemotherapeutic and biologic treatment combinations that are,increasingly ...
... Mobile Massage Team, (http://www.mobilemassageteam.com ), a leading ... wellness programs, promotional events, and special,affairs, announced ... area throughout,eastern Pennsylvania and the greater Philadelphia ... about the increasing interest in our on-site,seated, ...
... nationally recognized faculty will,present the very latest treatment ... course "Optimizing Adjuvant Breast Cancer,Strategies: From Biomarkers to ... It is challenging for practicing oncologists and other ... on the latest patient care,advances. This accredited course ...
Cached Medicine News:Health News:Metabolic Syndrome Raises Colon Cancer Risk 75% 2Health News:Metabolic Syndrome Raises Colon Cancer Risk 75% 3Health News:2008 HIMSS Davies Awards: Nation's Outstanding Healthcare Organizations Recognized 2Health News:2008 HIMSS Davies Awards: Nation's Outstanding Healthcare Organizations Recognized 3Health News:2008 HIMSS Davies Awards: Nation's Outstanding Healthcare Organizations Recognized 4Health News:2008 HIMSS Davies Awards: Nation's Outstanding Healthcare Organizations Recognized 5Health News:U-M to house leading drug database 2Health News:Latest Research on Breast Cancer Presented in a Virtual E-Conference CME Course 2Health News:Mobile Massage Team Announces Expansion of On-Site Seated Massage Services Throughout Eastern Pennsylvania and the Greater Philadelphia Region 2Health News:Nationally Recognized Faculty Presents Latest Advances in Care of Patients with Breast Cancer 2
(Date:9/30/2014)...  HealthLoop® released an app version of its doctor-patient ... and allows people to share medical device and activity ... technologies to enhance the HealthLoop experience for iPhone users, ... doctors between visits. "This new flood ... is exciting," says HealthLoop founder Dr. Jordan Shlain ...
(Date:9/30/2014)... VIEW, Calif. , Sept. 30, 2014 /PRNewswire/ ... tissue diagnostics market, Frost & Sullivan recognizes Ventana ... Roche Group, with the 2014 North American Frost ... to strict quality practices along with a focus ... Ventana a global leader in tissue-based cancer diagnostic ...
(Date:9/30/2014)... 2014  Georgia-Pacific Professional is a leading provider ... a wide range of away from home applications. ... in healthcare, including hospitals, long-term care facilities, surgical ... its healthcare products and solutions to the dental ... of infection control in the dental office," said ...
Breaking Medicine Technology:HealthLoop Integrates with Apple's HealthKit Enabling Patients to Share Health Data with Their Doctors Right from their iPhone 2Frost & Sullivan applauds the diversity of Ventana products and services for the cancer diagnostics market 2Frost & Sullivan applauds the diversity of Ventana products and services for the cancer diagnostics market 3Frost & Sullivan applauds the diversity of Ventana products and services for the cancer diagnostics market 4Georgia-Pacific Professional Brings Its Success in Medical Solutions to the Dental Community 2Georgia-Pacific Professional Brings Its Success in Medical Solutions to the Dental Community 3
... Mass., Nov. 11, 2010 Interleukin Genetics, Inc. (OTCQB: ILIU) ... ended September 30, 2010. Revenue for the three ... $0.3 million for the same period in the prior year. ... as we experience positive growth. Research and development ...
... NEW YORK, Nov. 11, 2010 /PRNewswire-Asia-FirstCall/ -- American ... ("the Company" or "AOBO"), a pharmaceutical company dedicated ... commercialization of a broad range of prescription and ... of AOBO Wujia Rongxue Oral Liquid, ("AWRO Liquid"), ...
Cached Medicine Technology:Interleukin Genetics Reports Third Quarter 2010 Financial Results 2Interleukin Genetics Reports Third Quarter 2010 Financial Results 3Interleukin Genetics Reports Third Quarter 2010 Financial Results 4Interleukin Genetics Reports Third Quarter 2010 Financial Results 5American Oriental Bioengineering Introduces Wujia Rongxue Oral Liquid 2
... For use as a ... detecting IgG antibody to Toxoplasma ... to rubella virus (rubella IgG), ... IgG) and IgG antibody to ...
... The VITROS HBsAg assay is ... by the U.S. Food and ... in a random,access format on ... Intellicheck. Now you can run ...
... The Total PSA method for ... immunoassay module is an in vitro ... total prostate specific antigen (TPSA) in ... used as an aid in the ...
... based on sequential binding of HCG from ... for the *-chain of HCG) immobilized on ... the *-chain of HCG) conjugated to the ... chromogenic substrate is added and colors developed. ...
Medicine Products: