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.
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.
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.