Drugmaker Endo Stops Selling Opioid Opana Due to Widespread Abuse

Drugmaker Endo Stops Selling Opioid Opana Due to Widespread Abuse

The FDA had asked Endo to withdraw the extended-release oxymorphone drug last month, citing concerns that its benefits don't outweigh its risks, particularly given its role in an HIV outbreak in IN tied to injection abuse of the drug.

The agency says the request was based on its concern that the benefits of the drug may no longer outweigh its risks.

The maker of opioid painkiller Opana ER is pulling the drug off the market at the request of federal regulators because it's being abused. That's caused some who abuse Opana ER to inject the drug more frequently. In the spring, the FDA reviewed data and determined that Opana ER was being abused by injection, a practice that it also linked to an outbreak of HIV, hepatitis C and cases of the blood disorder thrombotic microangiopathy. When the FDA urged Endo to pull Opana ER on June 8, company shares plunged 13.4 percent.

"With Opana ER now officially being pulled, focus shifts to protecting the potential lost EBITDA margin associated with the product, which we estimate to be in the range of 60.0% to 65.0%", wrote Raymond James analyst Elliot Wilbur in a note on Thursday, July 6.

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The drugmaker expects to incur a pre-tax impairment charge of about $20 million in the second quarter, Endo said.

Friday, the FDA asked that Opana ER be taken off the market after what they call careful consideration. The company issued a statement saying it has taken a strong stance against abuse, seeking to reduce instances of misuse of Opana ER, but the issue has persisted and it is creating more problems than it is solving.

Dublin, Ireland-based Endo, which has USA headquarters in the Philadelphia suburb of Malvern, said it will work with the FDA to try to minimize disruption for patients, who will need to switch to alternative treatments.

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