"We are facing an opioid epidemic - a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse", Dr. Scott Gottlieb, the FDA's newly appointed commissioner said in a statement.
If Opana ER sounds familiar, it's because it was the drug of choice for many addicts at the center of an HIV outbreak in IN in 2015. The move follows an FDA advisory committee vote of 18-8 in March concluding the drug's risks were greater than the benefits.
Gottlieb said the agency will "continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse". In 2012, Endo replaced the original formulation of Opana ER with a new formulation meant to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.
In explaining its move, though, the FDA said post-marketing data indicated more people were finding ways to inject the drug contained in the pill, despite a 2012 reformulation that was created to prevent such abuse.
Endo is reviewing the FDA's request and evaluating all its options "as we determine the appropriate path forward", it said in a statement.
"The FDA's decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product's reformulation", it said.
The FDA indicated that if Endo declines to remove Opana ER voluntarily, the agency would withdraw approval for the opioid. The FDA intends to continue issuing warnings and informing the public about the risks of Opana use in the meantime.
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The agency has been criticized in the past for examining the safety and effectiveness of individual opioid painkillers without considering the wider impact each could have on the nation's epidemic.
Opioids were involved in more than 33,000 deaths in 2015 and opioid overdoses have quadrupled since 1999, according to the Centers for Disease Control and Prevention. The FDA warned that if Endo chose not to, it would take steps to require removal from the market.
The FDA didn't agree, refusing to let Endo market the new formulation as abuse deterrent when it granted approval for sales several years ago.
Cities and states have started suing makers of opioid drugs, saying that they've pushed their drugs on doctors and patients alike, helping drice addiction. "This action will protect the public from the further potential for misuse and abuse of this product".
Endo's shares fell 12.2 percent to US$12.10 in extended trading.
Last year, Opana ER generated almost $159 million in revenue, although sales have slowed more recently.