Navigation Links
Premier Research Announces Milestone New Drug Application
Date:3/4/2009

PHILADELPHIA, March 4 /PRNewswire/ -- Premier Research Group Limited, the international pharmaceutical services group, is pleased to announce its role in the submission of the New Drug Application for Acurox(R) (Oxycodone HCl/niacin) Tablets for the sponsor, Acura Pharmaceuticals. Premier Research provided full service clinical trial management for the pivotal Phase 3 clinical safety and efficacy study, which was conducted at their research centers, as well as provided the programming, data management, statistics, medical writing, regulatory strategy and FDA liaison for the NDA. Ron Spivey, Ph.D., Acura's Senior Vice President and Chief Scientific Officer responsible for the NDA submission remarked, "I have truly enjoyed working with the entire Premier Research group. This organization is the best CRO I have ever worked with."

"The ability of a pharmaceutical company to outsource both the clinical development and regulatory submission to a single CRO provides significant internal synergies to our clients. Moreover, our team exceeded client expectations for quality and timeliness of this submission, a true testament to the extraordinary talent and experience that exists within Premier Research. We are very proud of this accomplishment and our people," commented Dr. Troy McCall, Chief Operating Officer.

Acurox(R), a patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient, has a proposed indication for the relief of moderate to severe pain. Acurox(R) utilizes Acura Pharmaceuticals' patented Aversion(R) Technology, which is designed to deter misuse and abuse by intentional swallowing of excess quantities of tablets, intravenous injection of dissolved tablets and nasal snorting of crushed tablets.

The submission of the NDA for Acurox(R) Tablets adds to considerable and growing expertise of the company in the analgesic therapeutic area. James Ottinger, Vice President of Premier Research's Consulting and Compliance Division, noted, "This NDA is the first of three major applications to be submitted to the Division of Anesthesia, Analgesia and Rheumatology Products within the next nine months. This, coupled with a large number of open INDs in this Division currently being managed by our regulatory affairs group, offers us the opportunity to provide significant value to companies working in the analgesic space."

About Premier Research

Premier Research is a leading global solutions-driven CRO committed to therapeutic focus and operational expertise to deliver clinical trial services of the highest quality for biopharmaceutical and medical device companies. They are leaders in clinical research for analgesia, neuroscience, oncology, and infectious disease and have a wealth of experience in medical device and pediatric research.

Premier Research has 30 offices and operates in more than 30 countries across North America and Europe employing more 1,200 clinical professionals dedicated first and foremost to fulfilling each client's requirements in a timely, accurate, and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific and medical experts, and staff at our well-established network of dedicated clinical sites.

www.premier-research.com


'/>"/>
SOURCE Premier Research Group Limited
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Premier Micronutrient Launches Supplement for Hearing Health
2. CV Therapeutics Announces Archives of Internal Medicine Publication of Study Showing 20 Percent of Heart Attack Patients in Premier Registry Experienced Angina at One Year
3. Groundbreaking American Journal of Play from Strong National Museum of Play(R) Premiers July 2008
4. Premier Research Honored as Clinical Research Team of the Year at 2008 GCPj Awards
5. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
6. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
7. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
8. Researchers at Cleveland Clinic Identify Site of Dysfunction in HDL, Carrier of Good Cholesterol
9. Video: New Research Discovers Independent Brain Networks Control Human Walking
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Cleveland Clinic Researchers Identify Mechanism Behind Platelet Function and Potentially Fatal Blood Clot Formation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... June 23, 2016  In a startling report released today, ... residents by lacking a comprehensive, proven plan to eliminate prescription opioid ... ranking of how states are tackling the worst drug crisis in ... states – Kentucky , New Mexico ... . Of the 28 failing states, three – ...
(Date:6/23/2016)... , June 23, 2016 Research ... MEMS Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data ... analysis. Assessment of major trends with potential impact on the ... analysis of market segmentation which comprises of sub markets, regional ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... their offering. The current ... environment for MedImmune to enter. The US ageing population creates ... drive considerable growth for effective anti-influenza medications. The introduction of ... but development is still in its infancy. ...
Breaking Medicine Technology:
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs ... College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. ... treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, ... and his M.D from the David Geffen School of Medicine at UCLA. He trained ... Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where ...
(Date:6/25/2016)... ... 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland ... iHire in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness ... & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of ...
Breaking Medicine News(10 mins):