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After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.
Endo International announced on July 6, 2017 that it would voluntarily remove its extended release opioid drug from the market, in response to FDA's June 2017 withdrawal request. In a statement announcing the withdrawal, the company said it “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.”
The company noted in the statement “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.”
In June 2017, FDA asked Endo Pharmaceuticals to voluntarily remove Opana ER from the market based on postmarketing data that indicated a “significant shift in the route of abuse” after the drug was reformulated. This action represented the first time the agency requested a company remove an opioid from the market. FDA said it intended to move to withdrawal its approval of the drug if Endo did not remove it from the market.
Endo reformulated Opana ER in 2012 with the intention of making it resistant to the physical and chemical manipulation consistent with abuse. However, the agency said that data on the reformulated version of the drug did not appear to “meaningfully reduce abuse.” In a March 2017 advisory meeting, the agency voted 18–8 that the benefits associated with Opana ER no longer outweigh the risks.
“We are facing an opioid epidemic-a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Scott Gottlieb in a June 8, 2017 statement. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
FDA said it would continue to examine the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate in response to an opioid public health crisis.
Endo reports that the company plans to work with FDA to coordinate the orderly removal of the drug and recommends that patients consult with physicians.