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:5/3/2015)... May 03, 2015 “ BolehVPN ” was ... which features the latest and coolest technology products available to ... NewsWatch, conducted the review and shared with viewers how to ... does these days is on computers and even more so ... and meet people all over the world. In terms of ...
(Date:5/3/2015)... It is not too late to register to ... Memory of Lissa Anne Been in Arnold, Missouri on May ... event to honor her loving memory. It has benefited the renowned ... having turned 37, Lissa suffered a brain aneurysm . After ... 2012. This event is designed to serve as a remembrance of ...
(Date:5/2/2015)... May 02, 2015 Vancouver fencing company, QS ... provide valuable advice to prospective clients related to their questions ... to install railings around their decks and patios. While that ... that pop up once the person rolls up their sleeve ... installing a railing in finding a gate that matches it. ...
(Date:5/2/2015)... Delray Beach, FL (PRWEB) May 02, 2015 ... newspaper has selected The Delray Recovery Center as one ... Recovery Center is known in the addiction treatment field ... encourages staff members to innovate and to continue their ... promoting a positive workplace environment, never forgetting their purpose ...
(Date:5/2/2015)... May 02, 2015 As a ... issues of the face, neck and décolleté, radiofrequency ... with real potential for the success of vulvovaginal ... ThermiHealth Clinical Advisory Council, ThermiGyn’s Women’s Health Clinical ... ACGE, concluded that ThermiGyn’s temperature controlled radio frequency, ...
Breaking Medicine News(10 mins):Health News:A Method to Keep Private Information Secure was Featured on NewsWatch Television 2Health News:Renowned Brain Aneurysm Foundation to Benefit from Arnold, Missouri’s 3rd Annual Brain Aneurysm Walk in Memory of Lissa Anne Been 2Health News:Professional Staff at QS Fencing Company Now Provides Advice on Railings and Gates 2Health News:The Delray Recovery Center Named 2015 Top Workplace 2Health News:Study Demonstrates Efficacy of Temperature Controlled Radiofrequency for Vulvovaginal Laxity 2Health News:Study Demonstrates Efficacy of Temperature Controlled Radiofrequency for Vulvovaginal Laxity 3
... plan to combat the spread of avian influenza through ... to during the one-day meeting of Economic Community of ... agriculture, health, livestock, environment and integration. ,.,A statement ... the ministers "examined and adopted the plan for a ...
... Cup with young men demanding "patriotic" hairstyles in the ... dare to try unusual hairstyles when mass enthusiasm breaks ... Cup," observes Stefanie Koehn, president of the German hairstylists' ... ,Demand for "really weird styles" of dyeing surged after ...
... It has long remained a mystery how even in loud ... party with music and a cacophony of people// talking - ... showed that the brain chooses what to hear. ... But they do know that the cochlea is mapped out ...
... According to hospital statistics, government figures show only half of ... in reality many accidents// happen to occur on the busy ... to reduce by 40% overall the number of serious injuries ... a starting point - baseline - of the 1994-8 average ...
... Nutritional Sciences say that the glycemic index table is ... portions are consumed. This should come as a relief ... 25 years ago at U of T by Professors ... an important tool for the management of non-insulin diabetes ...
... today announced that it has launched the authorized generic version ... // ,The company has also launched the authorized ... mg, 20 mg, 40 mg and 80 mg yesterday, a ... company entered into separate agreements with Merck that enabled it ...
Cached Medicine News:Health News:World Cup Fans go for Patriotic Hairstyles 2Health News:Sound Separated into Sound Frequencies 2Health News:Sound Separated into Sound Frequencies 3Health News:Glycemic Index Works For Diabetes Patients 2
(Date:5/1/2015)... , May 1, 2015  An effective advisory ... provide non-binding but informed guidance to pharmaceutical organizations ... on investment, it is important for leaders to ... resources. Research and consulting leader ... assist pharmaceutical and medical device executives in identifying ...
(Date:5/1/2015)... /PRNewswire/ --Research and Markets ( http://www.researchandmarkets.com/research/vzcw2v/americas_clinical ) ... Analyzer Market by Product, by End-Users - Forecast to 2019" ... Chemistry Analyzers market is estimated to grow at a CAGR ... U.S., Canada , Mexico ... (RoA) are covered in this report. The Americas ...
(Date:5/1/2015)... , May 1, 2015 Following yesterday,s release of ... D, here are five things you need to know: ... market-based structure is unique among government programs. ... D is different than other parts of Medicare and other ... that submit bids to offer prescription drug benefits to enrollees. ...
Breaking Medicine Technology:New Study Presents Insights to Advisory Board Effectiveness in the Pharmaceutical Sector 2Americas Clinical Chemistry Analyzer (Semi-Automated Clinical Chemistry and Fully-Automated Clinical Chemistry) Market - Forecast to 2019 25 Things to Know About the CMS Part D Data Release 25 Things to Know About the CMS Part D Data Release 3
... Spirit is the premium APAP device in ... The AutoSet algorithm responds to the patients ... flow generator stores and reports comprehensive clinical ... AutoSet devices combine integrated humidification and a ...
Paediatric tubes have decreased sample volumes and are ideal for small childrens' veins and geriatric patients....
... System provides the capability to ... middle of surgery while retaining ... incision. The system is also ... for large patients while remaining ...
These retractors, made of rugged Noryl® resin, are pre-sterilized and packaged singly in double peel-pouches for easy delivery to the sterile surgical field....
Medicine Products: