Endo to Pull Opana From the Market Following FDA Request

Endo International has announced its plan to withdraw Opana ER (oxymorphone hydrochloride extended release) from the market, following the FDA’s request to remove the reformulated opioid pain medication in June.

Opana ER was first approved in 2006 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

FDA officials made the withdrawal request based on a review of available postmarketing data, which showed a significant shift in the route of abuse following the product’s reformulation from nasal to injection. According to the FDA’s statement, injection abuse of the reformulated drug has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder.

During the agency’s advisory committee meeting in March, a group of independent experts voted 18-8 that the reformulated medication’s benefits no longer outweighed its potential risks.

In the company’s press release, Endo announced its plans to work with the FDA to coordinate the orderly removal of the pain medication “in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their health care professionals.”

References

Endo provides updates on Opana ER [news release]. July 6, 2017. Endo’s website. http://www.endo.com/news-events/press-releases. Accessed July 6, 2017.

FDA requests removal of Opana ER for risks related to abuse [news release]. June 8, 2017. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm. Accessed July 6, 2017.