Navigation Links
SCOLR Pharma's Partner to Commence Bioequivalence Study of Ondansetron
Date:2/14/2012

BOTHELL, Wash., Feb. 14, 2012 /PRNewswire/ -- SCOLR Pharma, Inc. (OTCQB: SCLR) announced today that RedHill Biopharma Ltd., a license partner that had previously obtained the exclusive worldwide rights to use SCOLR's patented technology to develop a new version of ondansetron, will conduct a bioequivalence trial in Canada.  Both the US Food and Drug Administration (FDA) and Health Canada have reviewed the protocol for the study and have no objections.

RedHill submitted an Investigational New Drug application (IND) to the FDA and a Clinical Trial Application (CTA) to Health Canada seeking permission to compare the bioequivalence of its product, which it calls RHB-102, to Zofran® (ondansetron), which is manufactured by GlaxoSmithKline.  Zofran® is an anti-emetic drug (i.e. for prevention of nausea and vomiting) that is administered several times per day. RHB-102 is a once-daily controlled release tablet formulation of ondansetron, a serotonin 5-HT3 receptor antagonist.

RedHill Biopharma said publicly, based on advice received from its regulatory consultants, that subject to certain conditions, the study may be considered a pivotal trial (Phase III-equivalent) that may be used by the Company for a marketing application to the FDA.  RedHill Biopharma estimated the development costs of RHB-102, until submission of an application to the FDA, will total $2-3 million. 

Stephen Turner, President and CEO of SCOLR, said: "We believe that the RedHill Biopharma announcement again affirms the potential value of SCOLR's patented technology in developing new pharmaceuticals that improve on existing drugs.  We look forward to a successful outcome on this study and a promising ongoing relationship with RedHill."

About SCOLR Pharma:

Based in Bothell, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company focused on applying its formulation expertise and patented CDT® platforms to deve
'/>"/>

SOURCE SCOLR Pharma, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. SCOLR Pharma, Inc. Announces Initial Shipments of its Nutritional Products
2. SCOLR Pharma, Inc. Announces Second Quarter 2011 Financial Results
3. SCOLR Pharma, Inc. First Quarter 2011 Financial Results
4. SCOLR Pharma, Inc. to Present at Taglich Brothers 8th Annual Small Cap Equity Conference
5. SCOLR Pharma, Inc. Reports 2010 Financial Results, Provides Updates on Advances in Nutritionals, OTC Drugs
6. SCOLR Pharma, Inc. Receives Deficiency Letter from FDA on Pseudoephedrine Application
7. SCOLR Pharma, Inc. Retains Nicholas Hall & Company
8. SCOLR Pharma, Inc. Common Stock to Begin Trading on OTC Bulletin Board and OTCQB Stock Market on January 13, 2011
9. SCOLR Pharma, Inc. Announces Intention to Voluntarily Delist From NYSE AMEX Exchange
10. SCOLR Pharma, Inc. Reports Third Quarter 2010 Financial Results
11. SCOLR Pharma, Inc. Names Carl Johnson as Chairman; Former Chairman Michael Taglich Remains as Director
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... Markets ( http://www.researchandmarkets.com/research/vzhr6h/video ) has announced the addition ... Share, Growth, Trends and Forecast 2014 - 2020" report ... topic of fascination since the era of the cold war ... Soviet Russia. Earlier even a small glimpse of human form ...
(Date:1/23/2015)... , Jan. 23, 2015  A new analysis of Centers ... 2015 enrollment data shows that 81 percent of seniors ... and extra discounts at certain pharmacies. The findings were ... pharmacy plans are now the foundation of Medicare Part ...
(Date:1/23/2015)... and DUBLIN , Jan. 23, ... agreement with KRS Global Biotechnology, Inc. for the compounding, packaging ... compounded for shipment in the United States ... approved Outsourcing Facility capable of compounding naltrexone tablets in various ...
Breaking Medicine Technology:Video Telemedicine Market- Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 2Video Telemedicine Market- Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 3New Analysis: 81 Percent of Medicare Part D Seniors Choose "Preferred Pharmacy" Plans in 2015 2Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 2Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 3Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 4
... 2010 Pfizer Animal Health today announced an ... SYNB ), a privately held, Kansas City-based ... immunodiagnostic tests for companion and food production animals. ... immunodiagnostics, a methodology using antigen-antibody reaction to detect ...
... YORK, Dec. 29, 2010 Reportlinker.com announces that a ... Regenerative Medicine Markets ... way of treating injured and diseased human tissue by ... As such, astounding new advancements in the ability to ...
Cached Medicine Technology:Pfizer Animal Health to Acquire Synbiotics Corporation, Entering Diagnostics Sector 2Pfizer Animal Health to Acquire Synbiotics Corporation, Entering Diagnostics Sector 3Pfizer Animal Health to Acquire Synbiotics Corporation, Entering Diagnostics Sector 4Reportlinker Adds Regenerative Medicine Markets 2
(Date:1/22/2015)... For over 20 years, Dr. David Cruz of Cruz Chiropractic ... treated just about every type of injury that can result from ... same twenty-plus years, the team at Doctors on Liens ... possible doctor. With the combined breadth of experience between ...
(Date:1/22/2015)... Yesterday, Senator Holly Mitchell (D-Los ... Olsen (R-Modesto) were honored by the California Healthcare ... biomedical science, medical device and pharmaceutical innovation in ... “2014 Life Sciences Champion” award from CHI President ...
(Date:1/22/2015)... Payday lending practices in four southern states ... distress to the states that permit them, according to ... on Race and Wealth. , While they generate hundreds ... at the same time substantially depress economic activity, according ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Compare-autoinsurance.org has released a ... insured by an auto insurance policy . , Some ... policy. Clients should check the newly released blog post to see ... cars and dangerously damaged vehicles are some of the cars that ...
(Date:12/26/2014)... December 26, 2014 The US represents the ... report. In 2013, GlobalData’s forecast estimates that sales of branded ... market due to the high incidence of the disease, high ... 5EU, Japan, and China. Increased sales of CRC therapies over ...
Breaking Medicine News(10 mins):Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:Some Vehicles Cannot Be Covered By An Auto Insurance Policy! 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 3Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 4
... laser pointers have become a popular consumer item, delivering light ... have circulated on the Web about the potential hazards of ... at the National Institute of Standards and Technology (NIST) puts ... found that a green laser pointer emitted almost twice its ...
... HealthDay Reporter , TUESDAY, Aug. 3 (HealthDay News) ... their homocysteine levels may not be protected from second strokes ... studies found an association between homocysteine, an amino acid, in ... attack. Vitamin B supplements lower homocysteine levels, but whether this ...
... in the emergency room reduced by half the chances that ... according to a study published Aug. 4 in a theme ... . The special issue on violence and human ... researchers who immersed themselves at the Hurley Medical Center Emergency ...
... By Steven Reinberg HealthDay Reporter , TUESDAY, ... As of 2009, almost 3 in every 10 adults ... in 2007, according to a new government report released Tuesday. ... Disease Control and Prevention (CDC), also found that between 2007-2009, ...
... study of breast cancer survivors may help physicians ease a ... Eva Sevick, Ph.D., Director of the Center for Molecular Imaging ... (UTHSC), and Caroline Fife, M.D., Director of the Memorial Herman ... Their paper appears in the inaugural issue of ...
... , Two University of Iowa biologists have published a paper ... the hope of one day learning more about human developmental ... Proceedings of the National Academy of Sciences . ... of biology in the UI College of Liberal Arts and ...
Cached Medicine News:Health News:NIST researchers measure high infrared power levels from some green lasers 2Health News:Vitamin B May Not Guard Against Second Stroke, Heart Attack 2Health News:Vitamin B May Not Guard Against Second Stroke, Heart Attack 3Health News:University of Michigan study: Pep talk to teens in the ER helped reduce violence, alcohol misuse 2Health News:University of Michigan study: Pep talk to teens in the ER helped reduce violence, alcohol misuse 3Health News:Number of Obese Adults Keeps Rising, CDC Says 2Health News:Number of Obese Adults Keeps Rising, CDC Says 3Health News:New imaging technique could help physicians ease the aftermath of breast cancer 2Health News:U. Iowa biologists publish findings on cell interactions 2
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: