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^®. On September 9, 2015 OXAYDO^® was launched for commercial distribution in the United States.

OXAYDO^®, which utilizes Acura’s AVERSION^® Technology, will be sold in bottles of 100 tablets in 5mg and 7.5mg strengths. On September 15, 2016, Egalet announced that a new 15mg strength of OXAYDO^® that they are developing achieved bioequivalence to a reference dose in support of a potential NDA supplement filing with a target filing date to the FDA in the second half of 2017. 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.