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 develop novel prescription pharmaceutical, over-the-counter (OTC), and nutritional products. Its CDT® drug delivery platforms are based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425-368-1050 or visit http://www.scolr.com/.

About RedHill Biopharma Ltd.:

RedHill Biopharma is an emerging Israeli biopharmaceutical company focused primarily on development and acquisition of late clinical-stage new formulations of existing drugs. The Company's current product pipeline includes a once-daily formulation of a leading congestive heart failure and high blood pressure drug, a once-daily formulation of a leading radiotherapy induced nausea and vomiting prevention drug, an oral thin film formulation of a leading triptan for the treatment of acute migraine, a combination therapy for the treatment of MAP infection in Crohn's as well as a companion diagnostic test for detection of the MAP bacteria, a combination treatment of resistant H. pylori bacteria causing ulcers, and a patent protected encapsulated formulation for bowel preparation ahead of certain gastro procedures. The Company's team includes prominent pharmaceutical experts. For more information please visit: www.redhillbio.com.

Forward looking statements:                                              

Any statements made in this press release that relate to future plans, events or performance are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These forward looking statements include statements regarding RedHill Biopharma's development of a drug formulation, conduct of a bioequivalence studies and future plans related to the development and marketing  of the drug formulation.  Factors that could cause these forward-looking statements to differ from actual results include delays by RedHill in commencing or completing the bioequivalence study, adverse clinical results or adverse regulatory determinations related to the study, competitive factors related to the drug product, economic factors including RedHill's ability to finance the development and commercialization of the product, and other risks and uncertainties discussed in the company's periodic reports on Form 10-K and 10-Q and other filings with the Securities and Exchange Commission.  SCOLR Pharma, Inc. undertakes no obligation to update or revise any forward-looking statements.

Contacts:

Investor Relations:
SCOLR Pharma, Inc.
425.368.1050

 

 


'/>"/>
SOURCE SCOLR Pharma, Inc.
Copyright©2010 PR Newswire.
All rights reserved

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:12/2/2016)...  PipelineRx, a leading medication management technology company ... of its SaaS-based telepharmacy platform, PowerGridRx™ , ... Midyear Clinical Meeting and Exhibition, December 5-7 in ... 300 hospital clients nationally, the Company is a ... dramatically improve pharmacy operations, enhance patient safety, and ...
(Date:12/2/2016)... 2016  Maxor National Pharmacy Services, LLC ("Maxor"), today announced ... ("PSI").  The combination of Texas -based Maxor ... PSI bring together both company,s clinical expertise and high-touch patient ... industry-leading specialty pharmacy. About Maxor ... , , ...
(Date:12/2/2016)... 2, 2016 Lianluo Smart Limited (Nasdaq: ... Company") which develops, markets and sells medical devices ... China and international markets, recently attended ... Treatment New Progress Forum, co-hosted by the Institute ... , Guangdong Provincial People,s Hospital and Cardiology ...
Breaking Medicine Technology:
(Date:12/2/2016)... Raleigh, NC (PRWEB) , ... December 02, 2016 , ... ... the Open Enrollment Period (or Annual Election Period), is ending December 7th. Currently-enrolled Medicare ... plan (Part C) or prescription drug plan (Part D) need to make changes during ...
(Date:12/2/2016)... New York, NY (PRWEB) , ... December 02, ... ... today, featuring an inspirational interview of two ostomy patients, standing as living proof ... million people suffer from digestive diseases and issues that spike around the holidays. ...
(Date:12/2/2016)... ... December 02, 2016 , ... Mediaplanet ... in USA Today, which covers the innovative treatments, therapeutic technologies, and revolutionized nutrition ... lives. “We are prolonging life 6 years in the last 3 decades,” says ...
(Date:12/2/2016)... ... 02, 2016 , ... Universal Medical Systems, Inc. (UMS) the ... company to offer robotic imaging to veterinary medicine is sponsoring the appearance of ... the American Association of Equine Practitioners 62nd Annual Convention from December 4-6, 2016 ...
(Date:12/2/2016)... , ... December 02, 2016 , ... Yisrayl Hawkins, at ... into how this current generation fits into Bible Prophecy. Yisrayl says this generation, known ... pointing to this conclusion, showing how the details line up exactly with Bible Prophecy ...
Breaking Medicine News(10 mins):