Endo to pay $200K penalty, overhaul marketing of opioid painkiller
- Endo International will pay a $200,000 fine and change how it markets its Opana ER painkiller, in a settlement with New York state. NY Attorney General Eric Schneiderman determined that Endo improperly marketed the opioid Opana (oxymorphone) by downplaying risks and touting the pill as "crush-resistant."
- The company will recalibrate its approach to marketing Opana, including revising its website to include clinical data showing related risks. The company must also implement a compliance program for its sales reps.
- Several other lawsuits have accused Endo and other companies of minimizing the risk of their painkillers, according to Stat.
For Endo, sales of Opana represent roughly 5% of the total revenues, earning $175.8 million in 2015. Opana was approved in June 2006 by the FDA as a non-crush resistant painkiller. However, over the next several years, drug makers were pressured to reformulate their painkillers to limit the ability of users to crush and abuse the pills.
In December 2011, Endo introduced and marketed crush-resistant version of Opana, although the company's own studies found Opana could still be crushed and ground.
"[The crush-resistance claim] may have bolstered Opana ER sales, but provided a false sense of security to health care providers and their patients," a statement from the NY Attorney General said.
Opioid-related overdose deaths have steadily increased in the U.S.. According to the Centers for Disease Control and Prevention (CDC), opioid overdoses caused 28,647 deaths in 2014—61% of the total number of drug-overdose deaths in the U.S.