- After a surprising request from the Food and Drug Administration in June, Endo International has voluntarily removed its extended-release opioid pain medication from the U.S. market.
- The drugmaker said Thursday afternoon that it would take a $20 million write-down on the move. Opana ER had sales of nearly $160 million in 2016, less than 5% of the company's revenues.
- While the FDA gave the company the option to remove the drug on its own, the June notice was hardly a request. The agency holds the power to revoke approval of the drug and force removal.
It took just about a month for Endo to comply with an FDA request to remove Opana ER (oxymorphone hydrochloride extended release) — the first time the agency has taken a step like this in the interest of public health. The move was one of new FDA Commissioner Scott Gottlieb’s first initiatives in the top slot at the agency. He has said publicly that fighting the opioid crisis is one of the agency's top priorities.
The removal was prompted by a review of post-marketing data that showed a shift in abuse patterns from nasal administration to injection and that the drug was associated with a serious outbreak of HIV and hepatitis C.
"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market," said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, at the time of the request.
While Endo’s short statement about the removal continued to insist that Opana ER is safe and effective when used properly, the company changed the formulation of the drug in 2012 in hopes of making it more abuse deterrent. Yet, the shift in formulation pushed abusers to stop crushing and snorting the drug and instead inject the drug, resulting in addicts sharing needles.
The opioid epidemic continues to sweep across the nation. According to the Centers for Disease Control and Prevention, the prescribing of opioids hit a peak in 2010 and have declined steadily since 2015. Yet, deaths from opioid overdose are increasing with nearly 91 Americans dying from opioid overdose every day (this includes both heroin and prescription opioids).
Deaths from prescription opioids — like oxycodone, hydrocodone and methadone — have quadrupled over the last 15 years, said the CDC.