Acuracet® Tablets

Acuracet® (oxycodone HCl/niacin/APAP) Tablets

Acuracet® 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.  Acuracet® contains two active analgesics: the opioid oxycodone HCl and acetaminophen (APAP).  Acuracet® Tablets are being developed in three tablets strengths of 5/30/325mg, 7.5/30/325mg, and 10/30/325mg.

Status

We opened an Investigation New Drug Application (IND) with the US Food and Drug Administration for Acuracet® in June 2008.  Subsequently, we transferred the active IND to King Pharmaceuticals Research and Development, Inc. (King), our development and commercialization partner.

Development Program

We demonstrated bioequivalence of Acuracet® Tablets to the reference listed drug, Percocet®.  Ongoing development, manufacture and commercialization of Acuracet® Tablets is the responsibility of King.

Percocet® is a registered trademark of Endo Laboratories, Inc.