Oxecta® Tablets

Oxecta® (oxycodone HCl, USP) CII Tablets

Oxecta® is a Schedule II narcotic indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Status

Oxecta® Tablets CII have been commercially available from Pfizer, Inc since January 23, 2012. Oxecta®, which utilizes Acura’s Aversion® Technology, will be sold in bottles of 100 tablets in 5mg and 7.5mg strengths. The FDA is requiring Pfizer to conduct a post approval epidemiological study to assess whether Oxecta® results in a decrease of the consequences of misuse and abuse.

Development Program

The NDA for Oxecta® Tablets included results from numerous clinical and laboratory studies assessing the efficacy and safety of Oxecta® Tablets and to demonstrate the intended abuse deterrent features and benefits. For a description of these features and important safety information, access the full prescribing information for Oxecta® at www.pfizer.com