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 Otti
'/>"/>

SOURCE Premier Research Group Limited
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:8/20/2014)... YORK , Aug. 20, 2014 ... market research report is available in its catalogue: ... Medical Records http://www.reportlinker.com/p0833392/EMR-2014-The-Market-for-Electronic-Medical-Records.html ... market for electronic medical records (EMR) for nearly ... comprehensive report of our findings. Our report has ...
(Date:8/20/2014)... England , August 20, 2014 ... be Conducted in the US  KalVista Pharmaceuticals ... macular edema (DME), today announces that it has begun ... novel plasma kallikrein inhibitor, KVD001, for the treatment of ... Sun of the Beetham Eye Institute, Joslin Diabetes Center; ...
(Date:8/19/2014)... KIRKLAND, Wash. , Aug. 19, 2014 ... solutions, will be exhibiting at the 2014 NPPA Summer ... The company will be showcasing its 340B software products ... leader in 340B splitting solutions, supplying over 400 customers ... a range of 340B solutions including its latest solution, ...
Breaking Medicine Technology:EMR 2014: The Market for Electronic Medical Records 2EMR 2014: The Market for Electronic Medical Records 3EMR 2014: The Market for Electronic Medical Records 4EMR 2014: The Market for Electronic Medical Records 5EMR 2014: The Market for Electronic Medical Records 6EMR 2014: The Market for Electronic Medical Records 7EMR 2014: The Market for Electronic Medical Records 8KalVista Pharmaceuticals Announces Start of Clinical Development for Novel Treatment for Diabetic Macular Edema 2KalVista Pharmaceuticals Announces Start of Clinical Development for Novel Treatment for Diabetic Macular Edema 3KalVista Pharmaceuticals Announces Start of Clinical Development for Novel Treatment for Diabetic Macular Edema 4Talyst Exhibits at the NPPA Summer Conference 2
...   Unigene Laboratories, Inc. (OTCBB: UGNE), today announced ... position of Chief Financial Officer. In this newly created position, ... company,s executive leadership team and lead the strategic direction ... Mr. Moskowitz joins Unigene after spending the previous ...
... 2012 Reportlinker.com announces that a new ... catalogue: Vaccines - ... This market research report package offers ... situation, trends and future outlook for vaccines ...
Cached Medicine Technology:Unigene Appoints David Moskowitz as Chief Financial Officer 2Unigene Appoints David Moskowitz as Chief Financial Officer 3Unigene Appoints David Moskowitz as Chief Financial Officer 4Unigene Appoints David Moskowitz as Chief Financial Officer 5Vaccines - Asia 2
(Date:8/20/2014)... York, New York (PRWEB) August 20, 2014 ... with the use of power morcellators ( http://www.injurybeacon.com/power-morcellator/ ) ... LLP notes that two U.S. Senators from New York ... to seek a recall of the devices. In a ... Schumer, both Democrats, also implored the agency to seriously ...
(Date:8/20/2014)... contrast to evidence that the amygdala stimulates stress ... Research Center, Emory University have found that the ... during the early development of nonhuman primates. , ... Journal of Neuroscience . , The amygdala is ... important for responses to threatening situations and learning ...
(Date:8/20/2014)... Reinberg HealthDay Reporter TUESDAY, ... that dismantles a baby,s immune system is twice as common ... million infants says. This is the first evaluation of ... condition known as severe combined immunodeficiency (SCID), or "Bubble Boy" ... this condition by the boy in the bubble, who was ...
(Date:8/20/2014)... Santa Rosa, CA (PRWEB) August 20, 2014 ... is the 12 per diode panel band perfect spectrum that ... plants are most likely to use during photosynthesis. A ... spectral bands is that they almost exclusively reside between 440-480 ... 620-680 on the red side of the spectrum. The KIND ...
(Date:8/20/2014)... 2014 Braverman Eye Center is now ... their experienced surgeons trained in PresbyLasik. The Braverman Eye ... lost or inaccurate vision. Their diligent service and adoption ... making it possible for Presbyopia patients to have better ... in people in the age group of 40 to ...
Breaking Medicine News(10 mins):Health News:Power Morcellator News: Bernstein Liebhard LLP Notes Senators’ Letter Seeking FDA Morcellator Recall 2Health News:Power Morcellator News: Bernstein Liebhard LLP Notes Senators’ Letter Seeking FDA Morcellator Recall 3Health News:Power Morcellator News: Bernstein Liebhard LLP Notes Senators’ Letter Seeking FDA Morcellator Recall 4Health News:Maturing brain flips function of amygdala in regulating stress hormones 2Health News:Maturing brain flips function of amygdala in regulating stress hormones 3Health News:'Bubble Boy' Disease May Be More Common Than Thought 2Health News:'Bubble Boy' Disease May Be More Common Than Thought 3Health News:Cheap LED Grow Lights Are Quickly Being Replaced by Premium Grow Lights 2Health News:Braverman Eye Center Now Offers Multifocal PresbyLasik in Florida by Trained Surgeons 2
... for young people do not always provide the same quality ... As our population ages and requires more healthcare, hospitals need ... over 65s and implement programs to meet their distinct needs, ... St. Michael,s Hospital. The study, published in the June ...
... (HealthDay News) -- People who seek treatment in an emergency ... likely to be readmitted to the hospital as those who ... The finding suggests that emergency departments can help reduce the ... were to present the study Friday at the Society for ...
... Reinberg HealthDay Reporter , THURSDAY, June 2 ... Americans to eat healthier meals and fight the obesity ... icon called MyPlate. MyPlate replaces the U.S. Department ... but had become too complicated in ensuing years, many ...
... conserving therapy for women 70 years and older with ... opting for radioactive implants and those with estrogen positive ... an abstract being presented at the American Society of ... University Hospital researchers on Saturday, June 4. The ...
... are one step closer to helping millions of people ... or damage from treatment of diseases. The ... Oral Health and Rehabilitation, UofL School of Dentistry, and ... the salivary gland. The National Institutes of Health supported ...
... 2 (HealthDay News) -- Obesity and insulin resistance constitute a ... according to a new study that found drinking modest amounts ... condition. For their study, published online May 23 in ... people to either abstain from alcohol or drink one (women) ...
Cached Medicine News:Health News:Not all hospitals treat elderly the same 2Health News:Emergency Care May Be Key to Hospital Readmissions 2Health News:U.S. Serves Up New Nutrition Guidelines on 'MyPlate' 2Health News:U.S. Serves Up New Nutrition Guidelines on 'MyPlate' 3Health News:ASCO: Emerging trends in radiation therapy for women over 70 with early stage breast cancer 2Health News:UofL researchers uncover mechanism in saliva production 2Health News:Obesity Greater Risk for Fatty Liver Than Alcohol, Study Finds 2
... Stainless steel workbench top ... is adjustable from 25"-34". Available ... configurations. Accessories include shelves, drawers, ... Terra is an expert in ...
... metal frames ensure cleanroom ... cleanliness and chemical resistance. ... with user-friendly pnuematic controls ... Fixed footring standard. Five ...
... ideal modular cleanroom for biological safety ... require cleanliness (to Class 10/ISO 3) ... to create ultra-smooth surfaces that are ... One-inch radius corners simplify cleaning. Unique ...
Inquire...
Medicine Products: