Acurox® (oxycodone HCl) Tablets (without niacin)We and King Pharmaceuticals R&D ("King") are jointly developing opioid analgesic product candidates both with and without niacin utilizing our patented Aversion® Technology. In developing Acurox® Tablets (without niacin) we and King have completed two Phase 1 pharmacokinetic (PK) studies demonstrating: (a) Acurox® Tablets are bioequivalent to the anticipated reference listed drug under fasted conditions, and (b) Acurox® Tablets have greater total oxycodone plasma levels with a lower peak drug concentration under fed compared to fasted conditions. We expect these PK studies will provide the basis for establishing safety and analgesic efficacy of Acurox® Tablets for inclusion in a 505(b)(2) NDA submission to the FDA by King. We have also completed laboratory tests characterizing the impediments to abusing Acurox® Tablets by intravenous administration. In addition, King has completed a Phase 2 clinical like/dislike study of crushed Acurox® Tablets administered intranasally in recreational opioid abusers. On September 27, 2010, King and Acura met with the FDA to discuss the contents of an Acurox® Tablets NDA submission acceptable to FDA for filing. As a result of this pre-NDA meeting, we currently expect King to submit an NDA for Acurox® Tablets to the FDA in the first quarter of 2011.
Acura Pharmaceuticals Reports 3rd Qtr 2010 Financial Results And Product Development Update
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