OXAYDO™ (oxycodone HCl, USP) CII Tablets

OXAYDO™ 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

OXAYDO™ is FDA approved with its abuse deterrent features described in its label. On January 8, 2015 Acura entered into a licensing and collaboration agreement with Egalet US, Inc. and Egalet Ltd. which grants Egalet worldwide rights to commercialize OXAYDO™. Currently, Acura and Egalet will be working jointly to transition the product so that it can be launched in the U.S. as soon as commercially practical.

OXAYDO™, 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 OXAYDO™ results in a decrease of the consequences of misuse and abuse.

Development Program

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