The Food and Drug Administration has asked Endo Pharmaceuticals, the manufacturer of Opana ER, an extended-release semi-synthetic opioid painkiller, to remove the drug from the market, after the agency concluded that the drug’s potential for abuse outweighed its therapeutic value. Endo had reformulated Opana ER (oxymorphone hydrochloride) to make it more difficult to abuse, but the FDA determined that this change ultimately resulted in a “significant shift in the route of abuse of Opana ER from nasal to injection.”

Oxymorphone hydrochloride is known for the potent high that results when it is ground, mixed with water, and injected. REUTERS/Jason Reed/File Photo

The move marks the first time the agency has called for the removal of an opioid painkiller for public health reasons and comes after a panel of advisers concluded in March that the drug’s benefits did not outweigh the risks. “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. “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's analysis of data gathered after the drug was approved showed that injection abuse of reformulated Opana ER (oxymorphone hydrochloride) was linked with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder called thrombotic microangiopathy. “This action will protect the public from further potential for misuse and abuse of this product.”

Opana was linked to the 2015 HIV outbreak in the rural Indiana community of Austin that resulted in dozens of confirmed HIV cases in a town of only around 4,000 people.
The U.S. Food and Drug Administration asks pharmaceutical manufacturer Endo International plc to withdraw its long-lasting (12 hours) opioid painkiller, Opana ER, from the market after an FDA panel concluded the drug's benefits no longer outweighed the risks of abuse. Endo is evaluating its options.