Day of reckoning for Opana?

Opana (oxymorphone ER) will be put under the spotlight at a Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, The meeting is to be held in Maryland, USA, on March 13 and 14 and will be available to the public via webcast.

The committees will be asked to discuss safety issues related to Endo’s reformulated Opana ER. Although the reformulated version of Opana ER was designed by Endo to have abuse-deterrent properties based on its physicochemical properties (that is, it is resistant to snorting), it wasn't granted abuse-deterrent labeling by the FDA, which noted that the reformulated drug might be easier to inject.

Safety concerns cited by the FDA to be discussed at the Joint Meeting include escalating rates of abuse by injection of oxymorphone, an unprecedented outbreak of HIV in a rural Indiana county associated with the intravenous abuse of reformulated Opana ER and  a potentially fatal bleeding disorder resembling thrombotic thrombocytopenic purpura (TTP) which has been linked to polyethylene oxide (PEO), an excipient added to reformulated Opana ER to deter abuse.

The committees will also discuss abuse of generic oxymorphone ER and oxymorphone IR products.

It will then be put to the vote of the convened panel whether the benefits of Opana ER continue to outweigh its risks.

Both the FDA and Endo have declined to state whether there was any prospect of Opana ER being removed from the US market.


https://www.fda.gov/AdvisoryCommittees/Calendar/ucm536620.htm

https://www.fda.gov/downloads/Advis...icDrugProductsAdvisoryCommittee/UCM545762.pdf

https://www.fda.gov/downloads/Advis...icDrugProductsAdvisoryCommittee/UCM545760.pdf

http://seekingalpha.com/article/4054181-fda-panel-re-examine-opana-er