AVERSION® oxycodone (oxycodone HCl, USP) CII Tablets

AVERSION® oxycodone 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

AVERSION® oxycodone, (formerly Pfizer Inc.’s OXECTA®) is FDA approved with its abuse deterrent features described in its label. AVERSION® oxycodone, as well as other AVERSION® Technology products in development, is available for licensing.

AVERSION® oxycodone, which utilizes Acura’s AVERSION® Technology, will be sold in bottles of 100 tablets in 5mg and 7.5mg strengths. The FDA is requiring a post approval epidemiological study to assess whether AVERSION® oxycodone results in a decrease of the consequences of misuse and abuse.

Development Program

The NDA for AVERSION® oxycodone Tablets included results from numerous clinical and laboratory studies assessing the efficacy and safety of AVERSION® oxycodone Tablets and to demonstrate the intended abuse deterrent features and benefits.