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:10/30/2014)... Diego, Calif. (PRWEB) October 30, 2014 ... longer mutually exclusive concepts in the medical-grade skin ... on the development of uniquely potent topical dermatological ... Health System ( http://www.RefinitySkinScience.com ) with patented COSMEDERM®-7 ... available glycolic acid concentrations (50% and 70%) and ...
(Date:10/30/2014)... (PRWEB) October 30, 2014 Radio listeners ... raising questions about the impact of traditional radio commercials ... method most likely to influence a purchasing decision. , ... of 525 consumers conducted by radio marketing company CRN ... categories, isolating the results of respondents who indicated they ...
(Date:10/30/2014)... Toronto, Canada (PRWEB) October 30, 2014 ... the area’s leading provider of non-medical, in-home senior care, ... activity to increased brain health. , The study, performed ... the ages of 60 and 78 over a week-long ... as opposed to daily physical activity. By examining the ...
(Date:10/30/2014)... 2014 USARAD Holdings Inc ... and specialty telemedicine solutions provider, including SecondOpinions.com ... existing teleradiology services at Mission Bend ER, it ... telemedicine services, to the state-of-the-art, 24/7, freestanding ER ... of this innovative partnership, there will be many ...
(Date:10/30/2014)... TX (PRWEB) October 30, 2014 ... released today its 2014 third quarter infection rates ... Texas boasted infection rates of only two percent ... patient satisfaction scores exceeding 98 percent. , “We ... quarter, which included rising satisfaction scores,” said Robert ...
Breaking Medicine News(10 mins):Health News:Cosmederm Redefines Peel Science Standard with Launch of Refinity® Skin Health System 2Health News:Cosmederm Redefines Peel Science Standard with Launch of Refinity® Skin Health System 3Health News:Cosmederm Redefines Peel Science Standard with Launch of Refinity® Skin Health System 4Health News:CRN Research On Radio Messaging Effectiveness Now Available In Four Specific Product Categories 2Health News:CRN Research On Radio Messaging Effectiveness Now Available In Four Specific Product Categories 3Health News:Home Care Assistance – Halton/Peel Region, a Top Provider of In-Home Care, Responds to Study Linking Exercise to Healthier Senior Brains 2Health News:Home Care Assistance – Halton/Peel Region, a Top Provider of In-Home Care, Responds to Study Linking Exercise to Healthier Senior Brains 3Health News:USARAD HOLDINGS INC, SECONDOPINIONS.COM® Pioneers Specialty On-Demand Telemedicine And Second Opinion Service At Houston-Based, Mission Bend Freestanding ER Chain 2Health News:USARAD HOLDINGS INC, SECONDOPINIONS.COM® Pioneers Specialty On-Demand Telemedicine And Second Opinion Service At Houston-Based, Mission Bend Freestanding ER Chain 3Health News:Victory Healthcare Releases Q3 Satisfaction, Infection Rates 2Health News:Victory Healthcare Releases Q3 Satisfaction, Infection Rates 3
... 25 OPKO Health, Inc. (Amex: OPK ),today ... C.,Pfenniger, Jr. to its Board of Directors. The company ... Mr. Pfenniger was,appointed to fill the vacancy created by ... created Board position., "The addition of Tom Beier ...
... $154 million, Announces Full Year 2008 Revenue Guidance of $204 ... and Reiterates ... Inc. (Nasdaq:,NUVA), a medical device company focused on developing products ... financial results for the full year ended December,31, 2007 and ...
... HOLLYWOOD, Calif., Jan. 25 IPC The,Hospitalist Company, Inc. ... announced yesterday the initial public offering of 5,200,000,shares of ... of $16.00 per share.,The Company has agreed to sell ... agreed to sell the remaining 1,900,000 shares of,common stock. ...
... Baxa Corporation announces,the launch of a targeted campaign ... delivery of quality therapy to patients, promoting,research and ... patients receiving IV therapy. The new campaign is ... Nurses Day. That day -- January 25, 2008 ...
... many as 30,000 deaths each year, study says , , ... contraceptives greatly reduce their risk of developing ovarian cancer, and ... new study confirms. , The use of oral contraceptives has ... cancer. The authors of the new study say their findings ...
... SAN DIEGO, Jan. 25 Plans put forward ... to healthcare will prove,impractical without more physicians and ... and Nurse Supply: The Missing Piece of the ... Healthcare, the largest,healthcare staffing company in the United ...
Cached Medicine News:Health News:OPKO Health Announces Changes to Board of Directors 2Health News:OPKO Health Announces Changes to Board of Directors 3Health News:NuVasive Announces Preliminary Unaudited Full Year 2007 Financial Results 2Health News:NuVasive Announces Preliminary Unaudited Full Year 2007 Financial Results 3Health News:IPC The Hospitalist Company, Inc. Prices Initial Public Offering 2Health News:Baxa Corporation Launches Campaign to Recognize IV Nurse Day and Introduce the New PadLock(R) Set Saver 2Health News:Baxa Corporation Launches Campaign to Recognize IV Nurse Day and Introduce the New PadLock(R) Set Saver 3Health News:Oral Contraceptives Cut Ovarian Cancer Risk 2Health News:Oral Contraceptives Cut Ovarian Cancer Risk 3Health News:Report: Too Few Physicians, Nurses to Implement Presidential Candidates' Health Reform Plans 2Health News:Report: Too Few Physicians, Nurses to Implement Presidential Candidates' Health Reform Plans 3
(Date:10/30/2014)... , Oct. 30, 2014  Nektar Therapeutics (Nasdaq: ... the third quarter ended September 30, 2014 on Thursday, ... markets. Howard Robin , president and chief executive ... results beginning at 5:00 p.m. Eastern Time (ET)/2:00 p.m. ... and a live audio-only Webcast of the conference call ...
(Date:10/30/2014)... --  Auxilium Pharmaceuticals , Inc. (NASDAQ: ... today announced financial results for the third quarter ... corporate, commercial, regulatory and clinical development updates from ... pleased with the continued momentum and strong performance ... this quarter, especially the XIAFLEX franchise, which more ...
(Date:10/30/2014)...  TWi Pharmaceuticals, Inc. today announced that it has ... Drug Administration (FDA) on its Abbreviated New Drug Application ... generic equivalent to Eisai Inc.,s Aricept® 23mg.  Aricept® 23mg ... TWi Pharmaceuticals is preparing to launch the product in ... USA , at the earliest time ...
Breaking Medicine Technology:Nektar to Announce Financial Results for the Third Quarter 2014 on Thursday, November 6, 2014, After Close of U.S.-Based Financial Markets 2Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 2Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 3Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 4Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 5Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 6Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 7Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 8Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 9Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 10Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 11Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 12Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 13Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 14Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 15Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 16Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 17Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 18Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 19Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 20Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 21Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2014 Financial Results 22
... EntreMed, Inc. (Nasdaq: ENMD ) announced today that ... with YA Global Master SPV Ltd. ("YA Global"), a fund ... has the option, at its sole discretion, to sell, from ... to YA Global.  Concurrent with the signing of the SEDA, ...
... NEWPORT NEWS, Va., June 28, 2011  Burlington Medical ... new product into its inventory. The Single Swing-Arm Drape ... protects the worker from any scattered beams of radiation ... The black vinyl drape is 39-and-a-half inches wide ...
Cached Medicine Technology:EntreMed Enters into $7.5 Million Equity Facility and Initiates $1.1 Million Drawdown 2EntreMed Enters into $7.5 Million Equity Facility and Initiates $1.1 Million Drawdown 3EntreMed Enters into $7.5 Million Equity Facility and Initiates $1.1 Million Drawdown 4Burlington Medical Supplies Introduces Single Swing-Arm Drape 2
... Ankle Orthosis enables the clinician to ... ankle joint to control muscle imbalance ... a pair of bilateral turnbuckles, controlling ... Simply adjust the turnbuckle to gradually ...
... Protection,Protects the heel while maintaining the ankle ... contact with a soft, cushioning AliPlast™ foam ... and liner cradles the heel in a ... change position freely in bed from side-lying ...
... Pediatric Ankle Cryo/Cuff is specifically designed to ... Using a combination of controlled compression and ... pain. The Pediatric Ankle Cryo/Cuff is ideal ... episodes in hemophilia.,The Pediatric Ankle Cryo/Cuff is ...
SCD Sequential Compression System Intermittent Pneumatic Compression...
Medicine Products: