A pharmaceutical company behind a popular painkiller brand linked to rising rates of abuse agreed to a request from the Food and Drug Administration to pull the pill off the market. Endo "continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER when used as intended", according to the release.
In March, an independent panel of advisers to the FDA voted in majority that Opana ER's benefits no longer outweighed its risks.
The move comes almost 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.
"The FDA's decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product's reformulation", the FDA said in a statement June 8.
The drugmaker expects to incur a pre-tax impairment charge of about $20 million in the second quarter, Endo said.
The decision to pull Opana ER from the USA market also comes as the Center for Lawful Access and Abuse Deterrence on 3 July petitioned FDA to require companies that do not have abuse-deterrent opioids to convert products to such formulations within three years or have their products removed from the market. In 2016, Opana ER brought in net sales of $158.9 million and $35.7 million for the first quarter of 2017.
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.
Going forward, Endo says it plans to work with the FDA to coordinate Opana's exit from the market "in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals".