FDA committees consider opioid painkiller abuse risk outweighs benefits

Amid ongoing US public health concerns about the use of opioid-based painkillers because of the threat of addiction, the risk posed by a product sold by Ireland-incorporated Endo International (Nasdaq: ENDP) is now seen as greater than the therapeutic benefit it offers.

That is the view of the Food and Drug Administration’s (FDA) Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees, which on Tuesday voted 18 to eight, with one abstention, that the benefits of reformulated Opana ER (oxymorphone hydrochloride extended release) no longer outweigh its risks.

"Endo remains confident that clinical research demonstrates that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients"