Endo has decided to voluntarily remove Opana ER (oxymorphone HCl extended-release tablets) from the market following the Food and Drug Administration (FDA)’s request for the withdrawal of the opioid medication.
“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,” the Company stated in a press release.
In June 2017, the FDA had requested the removal of Opana ER from the market after a review of postmarketing data showed a significant shift in the route of abuse from nasal to injection after the drug was reformulated. The abuse of reformulated Opana ER via injection had been linked to a serious outbreak of HIV and hepatitis C infections in addition to thrombotic microangiopathy. While the reformulated product met the regulatory standards for approval, the Agency concluded that the data did not demonstrate it could meaningfully reduce abuse.
Opana ER, an opioid agonist, is approved for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is required for an extended period of time. The Company plans to work with the FDA to minimize disruption for patients currently taking the medication. Patients currently on Opana ER should contact their clinicians to explore other treatment options.
For more information visit Endo.com.