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Premier Research Announces Milestone New Drug Application
News

Premier Research Announces Milestone New Drug Application

Premier Research Announces Milestone New Drug Application
News

Premier Research Announces Milestone New Drug Application

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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.

Premier Research Group Limited, the international pharmaceutical services group, announces its role in the submission of the New Drug Application for Acurox® (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®, 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® utilizes Acura Pharmaceuticals’ patented Aversion® 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.
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