Acurox® with Niacin Tablets
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
On April 22, 2010, the Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Advisory Committees to the US Food and Drug Administration (FDA) met jointly to discuss the New Drug Application (“NDA”) for Acurox® with Niacin Tablets and the results of clinical studies evaluating the addition of niacin for the purpose of reducing the misuse of oxycodone. The Committee voted that they do not have enough evidence to support the approval of the NDA for Acurox® with Niacin Tablets for the treatment of moderate to severe pain considering the deterrent effects of niacin as well as the potential deterrent effects of the other features specific to Acurox®. The FDA questioned the effectiveness of niacin included in Acurox® with Niacin but cited no concerns with the snorting and intravenous abuse limiting features of the product. The FDA is not bound by the Advisory Committees’ recommendation, but may take its advice into consideration when evaluating the NDA for Acurox® with Niacin. Acura and King will work with the FDA to determine the next steps for the Acurox® with Niacin development program.
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 explicit claims of abuse deterrence will not be permitted in product labeling unless such claims are supported by double blind controlled clinical studies demonstrating an actual reduction in product abuse by patients or drug abusers. We believe the cost, time and practicality of designing and implementing clinical 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 included in the proposed labeling of our NDA for Acurox® with Niacin Tablets 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 to discussions with and agreement by the FDA as part of the NDA review process. Because the FDA closely regulates promotional materials, even if the FDA initially approves labeling that includes a description of the abuse deterrent characteristics of the product, the FDA will continue to review the acceptability of promotional labeling claims and product advertising campaigns for our product candidates.
