Philadelphia, PA; March 4, 2009-Premier Research Group Limited, the international pharmaceutical services group, is pleased to announce its role in the submission of the New Drug Application for AcuroxxAE; (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.
AcuroxxAE;, 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. AcuroxxAE; utilizes Acura Pharmaceuticals' patented AversionxAE; 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 AcuroxxAE; 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.