Endo International plc continues to believe in the safety, efficacy, and favorable benefit-risk profile of OPANA® ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse. Nevertheless, after careful consideration and consultation with the FDA following the FDA's June 2017 withdrawal request, the Company has decided to voluntarily remove OPANA® ER from the market. As a result, the Company expects to incur a pre-tax impairment charge of approximately $20 million in the second quarter of 2017 to write-off the remaining net book value of its OPANA® ER intangible asset. Reported net sales of OPANA® ER were $158.9 million for full-year 2016 and $35.7 million for first quarter 2017.
Endo plans to work with the 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. Patients taking OPANA® ER should discuss treatment options with their prescribing physician at their next visit.
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. 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.
OPANA® ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.