Endo Pharmaceuticals (NSDQ:ENDP) said today that it will voluntarily pull its Opana ER painkiller from the market. The move comes just weeks after the FDA asked the company to pull the plug on its opioid, arguing that the benefits of the abuse-deterrent drug no longer outweigh the risks.
To write off the remaining net book value of the product, Endo said it expects to incur a pre-tax impairment charge of $20 million in the 2nd quarter of this year. Opana brought in $158.9 million in net sales in 2016.
The company stands by the safety and efficacy of its pain-relief product.
“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 company wrote in a statement. “To the contrary, Endo remains confident in the clinical research and other data demonstrating Opana ER’s safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients.”
The request from the FDA to remove Opana from the market marked the first time the federal regulatory watchdog urged a company to remove an opioid due to concerns of abuse.
Endo’s Opana ER won FDA approval in 2006 for the management of moderate-to-severe pain. Six years later, the company reformulated Opana ER with the intent to make it harder for people to snort or inject it.
But a review of postmarketing data showed that the reformulation may have encouraged users to shift from snorting Opana to injecting the painkiller by mixing it with large volumes of solvent.
The painkiller was even linked to a 2015 HIV outbreak in Indiana after people addicted to opioids shared needles while injecting Opana.
