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.
A primary market research survey of 401 opioid prescribing physicians suggests that regardless of whether Acurox® Tablets contain niacin or do not contain niacin, Acurox® has the potential for garnering a substantial share of immediate release opioid analgesics prescriptions, although there can be no assurance in this regard. This finding was confirmed in a separate primary market research study of 435 physicians which concluded the particular combination of ingredients [i.e. with or without niacin] does not appear to have a substantial effect on the estimated brand market share potential.
Acurox® with Niacin (oxycodone HCl/niacin) TabletsWe and King are analyzing the results from study AP-ADF-114 (Study 114), an abuse liability study comparing the like/dislike scores of excess oral doses of Acurox® with Niacin Tablets to excess oral doses of oxycodone HCl tablets alone without niacin. Study 114 was not included in the original NDA filing for Acurox® with Niacin Tablets for which we received an FDA Complete Response Letter ("CRL") in June 2009. We intend to complete our Study 114 analyses and associated Clinical Study Report and respond to the FDA's CRL for Acurox® with Niacin Tablets.