Endo Targets Opana ER Abuse-Deterrent Filing In 2016
This article was originally published in The Pink Sheet Daily
Endo continues to believe it can rebuild Opana ER, despite generic competition, by adding abuse-deterrent labeling and securing critical intellectual property protection.
You may also be interested in...
Abuse-deterrent opioids address a serious unmet need and help differentiate brands from the field of generics, but so far Purdue’s OxyContin remains the only opioid on the market with abuse-deterrent claims, even though FDA recently approved two new opioid analgesics.
Endo’s Opana ER reformulation, which uses proprietary technology to deter crushing, receives approval but no labeling language on crush-resistance or abuse deterrence, according to FDA. The company says a U.S. patent to be issued Dec. 13 will protect the new formulation until November 2023.
Positive Phase II data in wet AMD showing potential for dosing out to six months could spur partnering interest ahead of Phase III development.