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June 9, 2017

FDA Seeks Withdrawal of Endo's Opana ER, Citing Opioid Risks

  • Endo International says it is reviewing the FDA’s request that the company withdraw its opioid pain medication reformulated Opana® ER (oxymorphone hydrochloride extended release) from the market.

    The FDA said its request marks the first time that the agency has acted to remove a currently marketed opioid pain treatment from sale due to the public health consequences of abuse. And it won’t be the last time FDA takes steps against an opioid medication, Commissioner Scott Gottlieb, M.D. warned.

    “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,” Dr. Gottlieb said yesterday in a statement. “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.”

    The FDA cited concerns that the risks of Opana ER may now outweigh its benefits—the conclusion reached by the FDA’s Drug Safety Risk Management and Anesthetic and Analgesic Drug Products advisory committees in a recommendation to agency administrators made in March in an 18 to 8 vote, with one abstention.  

    In a statement, Endo emphasized that more than half the members of the advisory committees voiced their view that Opana ER remain on the market with additional regulatory restrictions to reduce the likelihood of misuse and abuse.  

    “Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward,” the company stated.

    However, Endo added: “Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed.”

    “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,” the company added.

  • Declining Revenues

    Endo has blamed competition from generics for Opana ER’s revenue declines over the past year. The drug generated $35.718 million in the first quarter, down 20% from Q1 2016. Last year revenues fell 10% from 2015, to $158.938 million.

    Endo is one of five opioid manufacturers sued by the state of Ohio late last month; the other four are Allergan, Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, Purdue Pharma, and Teva Pharmaceutical Industries and its Cephalon subsidiary. The companies are accused of violating the Ohio Consumer Sales Practices Act by engaging in fraudulent marketing about the risks and benefits of opioids, resulting in users becoming addicted.

    Tipping the proverbial risk-benefit scale, according to the FDA, is a change in how many users have abused Opana ER following the product’s reformulation. Abusers crushed and snorted Opana ER after the agency initially approved the drug in 2006. But when Endo reformulated Opana ER six years later to reduce the likelihood of misuse, abusers shifted to injection.

    According to the FDA, injection abuse of reformulated Opana ER has been associated with outbreaks of HIV/AIDS and hepatitis C, as well as cases of the blood disorder thrombotic microangiopathy.

    Dr. Gottlieb has consistently identified tackling opioid misuse as one of his highest initial priorities as FDA commissioner. While acknowledging past agency actions, he has also promised to “take even more forceful steps to address this crisis.”

    “Unquestionably, our greatest immediate challenge is the problem of opioid abuse,” he said May 15 in his first address to FDA employees. “The epidemic of opioid addiction is not a problem that FDA can solve alone. But we have an important role to play in reducing the rate of new abuse, and in giving healthcare providers the tools to reduce exposure to opioids to only clearly appropriate patients, so we can also help reduce the new cases of addiction.”

    Dr. Gottlieb took office last month after winning Senate confirmation by a 57 to 42 vote largely along party lines, with most Republicans in favor and Democrats opposed. Dr. Gottlieb, who was nominated in March by President Donald Trump, served as an FDA deputy commissioner during the administration of George W. Bush.

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