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.pfizerpro.com/hcp/oxecta.