The FDA stated that if Endo did not voluntarily recall the drug, the agency would formally withdrawal approval. But the company says it made a decision to voluntarily remove the drug from the market after "careful consideration and consultation" with the FDA.
The unprecedented move came in the wake of reports patients were crushing up the pills to inject.
The company noted that it continues to believe in the safety, efficacy, and favorable benefit-risk profile of OPANA ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse. They say the pills is safe and effective when administered properly, but will comply and work with the FDA on the issue.
Medicine to identify additional actions the agency should consider to address the opioid crisis, "with a particular focus on approaches the agency can take to improve its benefit-risk framework for opioids to support a more formal assessment of the public health risks and benefits".
Opana ER received approval in 2006, though the company introduced a newer version in 2012 created to make abuse via oral use or snorting more hard. The reformulation coated the pills in a way that made them hard to snort, but addicts shifted towards crushing and injecting the painkiller.
Although Endo had reformulated Opana with the intention of making it more hard to abuse, the FDA said last month that it had determined that this change ultimately resulted in a "significant shift in the route of abuse of Opana ER from nasal to injection". Injection abuse of reformulated Opana ER has been associated with an outbreak of HIV infection and hepatitis C virus infection, as well as cases of thrombotic microangiopathy, FDA said.