Opana ER, a potent extended-release opioid, was approved by the FDA for pain management in 2006. We say that because Endo argued that the FDA request "does not indicate uncertainty" that Opana ER is not safe or effective when taken as prescribed.
"We 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 regarding its potential for misuse and abuse", Commissioner Gottlieb added. "When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market", Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research said in the FDA's prepared statement.
The withdrawal marks the first time the agency taken steps to remove an opioid pain medication due to the public health implications and comes amid an intense national debate about the abuse of opioids. The agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks.
The FDA was able to link the shift from Opana inhalation to injection with a serious outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy, a risky blood disorder. The company defended its drug, a version of the medicine oxymorphone hydrochloride, citing the opioid's effectiveness in alleviating pain and Endo's efforts to prevent abuse.
As STAT has noted previously, Opana ER is meant to be swallowed and the contents released over 12 hours, which is known as extended release. "When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market".
From 2000 to 2015, almost 180,000 Americans died from overdoses of prescription opioids, and tens of thousands more have succumbed to heroin and fentanyl overdoses as the crisis has evolved.
For the first time ever, the Food and Drug Administration has asked a drug company to pull a painkiller off the market because it has such a high potential for abuse. "This action will protect the public from the further potential for misuse and abuse of this product". As a result, some who abuse Opana ER are injecting the drug more frequently.
FDA officials said their decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of the reformulated product from nasal to injection following the product's reformulation. The agency, in fact, determined the reformulation was not expected to "meaningfully reduce abuse" and declined to let the company describe the drug as abuse deterrent in the product labeling.
Last year, Opana ER generated almost $159 million in revenue, although sales have slowed more recently.