Acurox® with Niacin (oxycodone HCl/niacin) Tablets

Acurox® with Niacin is an immediate release opioid analgesic tablet with a proposed indication for relief of moderate-to-severe pain and is designed to deter common methods of misuse and abuse.

Status

Acura and Pfizer are analyzing the results from study AP-ADF-114 (Study 114), an oral abuse liability study comparing the like/dislike scores of Acurox with Niacin Tablets to oxycodone HCl tablets alone. Study 114 was not included in the original NDA filing for Acurox with Niacin Tablets submitted to the FDA in December 2008 and for which we received an FDA Complete Response Letter in June 2009. Pfizer and Acura continue to evaluate FDA’s complete response and is evaluating appropriate next steps.

Development Program

The NDA for Acurox with Niacin Tablets includes results from numerous clinical and laboratory studies assessing the efficacy and safety of Acurox with Niacin Tablets and to demonstrate abuse deterrent features and benefits, including the data and results from studies set forth in the table below.

Studies Conducted for Acurox with Niacin (click study number for summary of results)
AP-ADF-101 Phase I	Niacin dose-response (0-75mg)
AP-ADF-104 Phase I	Bioequivalence to non Aversion® Technology Reference Listed Drug
AP-ADF-108 Phase I	Single dose linearity and food effect
AP-ADF-109 Phase I	Multi-dose linearity
AP-ADF-106 Phase I	Evaluate effects of nasal snorting in subjects with a history of snorting and nasal drug abuse
AP-ADF-103 Phase II	Repeat dose safety and tolerability
AP-ADF-107 Phase II	Niacin dose-response (0-600mg)
AP-ADF-102 Phase II	Evaluate relative dislike of oxycodone HCl/niacin versus oxycodone HCl alone
AP-ADF-111 Phase II	Evaluate abuse liability of oxycodone HCl/niacin versus oxycodone HCl alone
AP-ADF-114 Phase II	Assess relative abuse potential of Acurox Tablets in non-dependent recreational opioid users
AP-ADF-105 Phase III	Evaluate safety and efficacy in relief of moderate to severe pain
Extraction Testing	Laboratory test quantifying I.V. abuse deterrent properties
Syringeability Testing	Laboratory test quantifying I.V. abuse deterrent properties

At this stage, the Company cannot provide any assurance that FDA will not require additional clinical studies for Acurox with Niacin Tablets.

Expectations Product Labeling

The FDA has publicly stated that abuse-deterrent label claims or indications require robust, long-term epidemiological data supporting a change in levels of abuse in the community over a reasonably long period of time. We believe the cost, time and practicality of designing and implementing clinical studies, as opposed to epidemiology studies, adequate to support explicit labeling claims of abuse deterrence are prohibitive. The FDA has stated that scientifically derived data and information describing the physical characteristics of a product candidate and/or the results of laboratory and clinical studies simulating product abuse may be acceptable to include in the product label. We intend to include in the labels of our Aversion® Technology product candidates (whether with or without niacin) both a physical description of the abuse deterrent characteristics and information from our laboratory and clinical studies designed to simulate the relative difficulty of abusing our product candidates. The extent to which such information will be included in the FDA approved product label will be subject of our discussions with an agreement by the FDA as part of the NDA review process for each of our product candidates. Further, because FDA closely regulates promotional materials, even if FDA initially approves labeling that includes a description of the abuse deterrent characteristics of the product, the FDA’s Division Drug Marketing, Advertising, and Communication (i.e. DDMAC) will continue to review the acceptability of promotional labeling claims and product advertising campaigns for our marketed products.