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:11/26/2014)... Santa Rosa, California (PRWEB) November 26, 2014 ... be making never before seen reductions in prices of ... and Liposomal Vitamin D3 . Discounts ... only. , GI for Life’s proprietary ColoVite ... leading board-certified gastroenterologists to promote colon health. One easy-to-take ...
(Date:11/26/2014)... IL (PRWEB) November 26, 2014 ... communication management solutions, has been award the ... Magazine. , This award comes as a great ... capabilities within the Lync ecosystem. Specifically, ISI offers ... all modes of Lync communication, including voice, video, ...
(Date:11/26/2014)... November 26, 2014 Medical suction and ... out of 5. This score represents steady growth in ... years to 2014 as a result of swelling demand ... machines, which are largely considered nondiscretionary. IBISWorld market research ... buyers have some degree of flexibility, given the low ...
(Date:11/26/2014)... Baton Rouge, Louisiana (PRWEB) November 26, 2014 ... and neck pain relief and specialists in minimally ... Dr. K. Samer Shamieh into the rapidly growing ... management specialists. The addition coincides with the ... cutting-edge, reliable medical treatment for Louisiana residents who ...
(Date:11/26/2014)... One of the most important and vital decisions a ... is choosing the ideal wedding dress and bridesmaid dresses. ... high quality outfits. Today, BellasDress.com has unveiled its new ... their suitable bridesmaid gowns here at discount prices. , ... scintillating and highlight all their most beautiful features while ...
Breaking Medicine News(10 mins):Health News:GI For Life Slashes Prices by 40% on Liposomal Vitamin D3 and ColoVite Colon Health Formula for a Limited Time 2Health News:ISI Telemanagement Solutions, Inc. has been Awarded the 2014 Microsoft Lync Pioneer Award 2Health News:Medical Suction & Vacuum Products Procurement Category Market Research Report from IBISWorld has Been Updated 2Health News:Medical Suction & Vacuum Products Procurement Category Market Research Report from IBISWorld has Been Updated 3Health News:Medical Suction & Vacuum Products Procurement Category Market Research Report from IBISWorld has Been Updated 4Health News:Louisiana Back Institute Welcomes Dr. K. Samer Shamieh into Medical Provider Network 2Health News:Royal Blue Bridesmaid Dresses Now Are Available for Christmas at BellasDress.com 2
... at the Puget Sound Health Care System, obese adults ... a recently discovered 'hunger hormone' than either normal-weight people ... David E. Cumming from the Puget Sound Health Care ... hormone called ghrelin could curb appetite and may cut ...
... study, zinc supplements could play a role in reducing the ... who tested three different methods of zinc administration in nearly ... diarrhea// defined as lasting more than seven days by 35 ... whether the zinc was given by a clinic worker or ...
... to researchers , there is a new study on ... sickened 30 people across six Western states last summer ... outbreak of Salmonella serotype senftenberg// most often found in ... grapes. ,Dr.Alicia, at the International Conference on Emerging ...
... up to almost one-half of their whole energy intake from ... a significant impact on their health.// ,Dr. Debra K. ... they get the nutrients, they get the energy they need, ... shown that snacking is growing among US children, who consume ...
... at Texas, have enrolled 10 patients with early stage bladder ... which is used for pancreatic and non-small cell lung cancer ... directly into the bladder, through a tube, and found that ... might be why there were few, if any, side effects ...
... talks about harmful radiations started during war times. Korean ... radiation emitted from radar equipment were no more likely ... lung, brain and testicular cancers--over a 40-year period//, according ... exposure to radar waves those who repaired and tested ...
Cached Medicine News:Health News:Decrease of 'Hunger Hormone' after Obesity Surgery 2Health News:Grapes, Melons Implicated in Outbreaks 2Health News:Healthy snacks improve nutrition of kids 2Health News:Microwave radiation has no hazards 2
(Date:11/26/2014)... , Nov. 25, 2014  Medtronic,s roughly ... has been widely discussed in the media for ... creating a stronger leading player in one of ... Information.  The healthcare market research firm said  the ... feature a diverse set of solutions spanning inpatient ...
(Date:11/26/2014)...   Heska Corporation (NASDAQ: HSKA ) ... of advanced veterinary diagnostic and other specialty veterinary products ... will attend The Benchmark Company, LLC,s Micro Cap Discovery Conference ... held at The Palmer House Hilton, 17 E. Monroe Street, ... 2:30 p.m. Please email hska@haydenir.com or contact your ...
(Date:11/26/2014)... 25, 2014  Array BioPharma Inc. (Nasdaq: ... its Chief Executive Officer, Ron Squarer ... conferences.  The public is welcome to participate ... Array BioPharma website:  www.arraybiopharma.com .Event: Piper Jaffray ...  Eastern Time Location: Palace Hotel, New York ...
Breaking Medicine Technology:Medtronic - Covidien: Beyond Taxes, Deal Will Create Patient Monitoring Power, according to Kalorama Information 2Medtronic - Covidien: Beyond Taxes, Deal Will Create Patient Monitoring Power, according to Kalorama Information 3Heska to Attend Benchmark Micro Cap Discovery Conference 2
... Pharmaceuticals, Inc., a Scottsdale, Arizona-based, emerging pharmaceutical company, ... of the assets of Scarista Limited. In particular, Prismic ... Limited, a wholly owned subsidiary of Amarin Corporation, ... a portfolio of issued U.S. and foreign composition ...
... ReportsnReports adds new market research report , Branded Prescription ... research says in 2011, the Branded PharmaVitae Universe achieved sales ... of 9.3% between 2003 and 2010, and a net sales ... grow by a CAGR of only 1.0%, with no growth ...
Cached Medicine Technology:Prismic Pharmaceuticals Acquires Scarista's Exclusive License to Amarin's Omega-3 Patents for CNS Disorders 2Branded Prescription Pharmaceutical Sales Outlook to 2016 - Sales to Rise by Just $29bn by 2016 2Branded Prescription Pharmaceutical Sales Outlook to 2016 - Sales to Rise by Just $29bn by 2016 3
Camera and light source in one compact "Plug-and-Play" device....
... are based on a completely new and revolutionary ... allows a tremendous image size without distortion. The ... the joint with less rotation of the telescope. ... tight and secure camera connection is introduced. It ...
... ProSpec, the system of choice for customers ... in medium throughput laboratories in more than ... milestone. Dade Behring is pleased to announce ... system., ,The customer centered development process ...
... Wavefront analysis with the WASCA Analyzer ... diagnosis. Unlike existing diagnostic techniques, the WASCA ... eye from thecornea to the retina. ... Analyzer also supplies higher order aberrations which ...
Medicine Products: