Endo Voluntarily Withdraws Opioid DrugBy
Endo International, a generics and specialty branded pharmaceutical company, has decided to voluntarily remove Opana ER (oxymorphone hydrochloride extended release), an opioid agonist indicated for severe pain management, from the market to prevent misuse and abuse.
Endo’s decision follows a request by the US Food and Drug Administration in June 2017 to voluntarily withdraw the drug to its high potential for abuse, marking the first time the FDA had taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.
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.
Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. While the product met the regulatory standards for approval, the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER. With more information about the risks of the reformulated product, the agency asked the company to remove the reformulated Opana ER from the market.
Endo said it 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. 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.
Source: Endo Internatonal