Acurox™ Tablets, our lead product candidate with Aversion Technology, is an orally administered immediate-release tablet containing oxycodone HCl as the sole active analgesic ingredient, a sub therapeutic amount of niacin, and a unique composition of functional inactive ingredients. Acurox™ Tablets will have an anticipated indication for treating acute moderate to moderately severe pain and will also have anticipated features to discourage or deter the most common methods of misuse and abuse including (i) intravenous injection of dissolved tablets, (ii) nasal snorting of crushed tablets and (iii) intentional swallowing of excess quantities of tablets.  Acurox™ Tablets are being developed pursuant to an active investigational new drug application (“IND”) on file with the FDA.  We and King intend to file a 505(b)(2) NDA for Acurox™ Tablets.  The FDA has confirmed in writing to us that the proposed NDA would qualify for a Section 505(b)(2) submission.   

Technical and Pre-Clinical Development Program and Regulatory Affairs Strategy

The technical and pre-clinical development program and regulatory strategy and status for Acurox™ Tablets are summarized below. At this stage, we can not provide any assurance that FDA will not require additional pre-clinical studies not listed below, or revise the Acurox™ Tablets regulatory requirements prior to their acceptance for filing of a 505(b)(2) NDA submission for Acurox™ Tablets.

Clinical Development Program

The clinical development program for Acurox™ Tablets is summarized below.  At this stage, the Company cannot provide any assurance that FDA will not require additional clinical studies prior to their acceptance for filing of a 505(b)(2) NDA submission for Acurox™ Tablets. 

Estimated Timing for submission of a 505(b)(2) NDA for Acurox™ Tablets

In September, 2007 we began enrolling patients in clinical Study AP-ADF-105, our pivotal phase III efficacy and safety study being conducted pursuant to a Special Protocol Assessment agreed with the FDA (see description of this study under the link “Study AP-ADF-105”).  We expect to submit our 505(b)(2) NDA for Acurox™ Tablets to the FDA in the second half of 2008. At the time of NDA submission we intend to request a priority review of the application by the FDA.  The FDA has publicly indicated a willingness to consider such action for product candidates incorporating abuse deterrence features.  No assurance however can be provided that the FDA will grant a priority review of our 505(b)(2) NDA submission. 

Expectations for Acurox™ Tablets Product Labeling

In the U.S., every product approved for commercialization pursuant to an NDA must be marketed in accordance with its FDA approved indications and associated product labeling.  The FDA has provided written guidance to us stating that an indication for abuse deterrence must be supported by data from two adequate and well-controlled clinical trials.  We do not intend to seek an indication for abuse deterrence for Acurox™ Tablets.  Instead, we are seeking an indication for Acurox™ Tablets for treatment of moderate to moderately severe pain.  The FDA has also provided written guidance to us stating that language regarding abuse deterrence (as opposed to an indication for abuse deterrence), which is supported by rigorous, scientific data, may be placed into appropriate sections of the Acurox™ Tablet product label.  In this regard, we intend to seek FDA approval of language in the Acurox™ Tablet product label describing the physical characteristics of the product and likely results if attempts are made to dissolve tablets in solvents suitable for intravenous injection, and/or snort crushed tablets, and/or swallow excess quantities of tablets.  We believe this product labeling strategy will provide a viable promotional platform for the commercialization of Acurox™ Tablets and other product candidates utilizing Aversion® Technology.  At this stage there can be no assurances that our product labeling strategy for Acurox™ Tablets will be successful or that FDA approved product labeling, if any, will provide a viable commercialization platform.