Endo International will voluntarily remove its opioid painkiller Opana ER from the market.
The move comes nearly a month after the Food and Drug Administration filed a withdrawal request for the painkiller, citing its misuse as a contributing factor to the nation's opioid crisis. While the drug is meant to be swallowed and released over the span of 12 hours, individuals can bypass the time release mechanism by crushing the drug into a fine powder and snorting or injecting it.
The FDA's request marked the first time the agency asked a drugmaker to remove an opioid from the market for public health reasons. The regulatory agency based its decision on data suggesting the route of misuse for Opana ER had generally shifted among drug users from the nasal cavity to injection. Illicit intravenous use of the drug has been linked to outbreaks of HIV, hepatitis C and a serious blood disorder.
"Endo plans to work with FDA to coordinate the orderly removal of Opana ER in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals," said the drugmaker. "Endo reiterates that neither the FDA's withdrawal request nor Endo's decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed."
The drug underperformed in the marketplace in the first quarter of this year with $35.7 million in sales. In the first quarter of 2016, Opana ER notched $44.7 million in sales, according to STAT.
Endo expects to incur a charge of about $20 million to write off the remaining net book value of Opana ER.
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