Oxecta® Tablets

Oxecta® (oxycodone HCl, USP) CII Tablets

Oxecta® is an immediate release opioid analgesic tablet 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 are now commercially available from Pfizer, Inc. 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