Signaling a Policy Change, FDA Seeks Removal of Opana ER from Market

In reaction to the current opioid crisis in the United States, the U.S. Food and Drug Administration has signaled a change in its long-held policy to consider a drug solely for its intended use to include a risk-benefit analysis for those who seek to abuse the drug. The agency’s initial effort in this policy change has been to seek the removal of the opioid pain medication Opana ER.

The agency announced on June 8, 2017 that it has asked Endo Pharmaceuticals, the company that manufactures oxymorphone hydrochloride, marketed as Opana ER, to withdraw its product from the American market due to the FDA’s assessment that the benefits of the medication “may no longer outweigh its risks.” The request, the first of its kind for an opioid pain medication, cites the public health consequences of abuse of this drug and is in keeping with recently-appointed agency Commissioner Scott Gottlieb, M.D.’s statement during the vetting process for his position that the nation’s opioid crisis would be the FDA’s top priority under his leadership.

Endo Pharmaceuticals reformulated Opana in 2012, six years after its FDA approval, in an effort to reduce its potential for abuse, making it unsuitable for crushing and snorting it is powder form as drug abusers had been doing. After the reformulation, however, drug abusers switched from snorting the medication to injecting it into their veins, leading to a HIV and hepatitis C outbreak in Indiana in 2015.

Gottlieb explained his agency’s withdrawal request for Opana ER in a press release:

“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. 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.”

For its part, Endo Pharmaceuticals, whose sales of Opana ER in 2016 totaled $158.9 million, said it is reviewing the FDA’s request and evaluating the company’s options going forward. Endo released a statement about their pain medication, approved for the use of moderate-to-severe pain relief needed on a continuous basis:

“Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.”

It would seem that the FDA and Endo agree that the intended use of the pain medication is not at issue, but the FDA has taken its assessment even further, taking into consideration the public health implications of Opana ER remaining on the market, remaining available not only to those who take the medication as prescribed but also those who use it as a drug of abuse.


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