- In an effort to cut the risk of opioid abuse and in an unprecedented first, the Food and Drug administration has asked Endo Pharmaceuticals to voluntarily pull its extended release oxymorphone, Opana ER, from the shelves.
- This follows analysis of post-marketing data showing a shift from nasal to injected abuse of the reformulated drug, despite Endo's claim that the 2012 formulation made the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. The move is the first time that the FDA has moved to remove an opioid medication from sale because of public health consequences of abuse.
- Irish parent company Endo International's share price fell by 14.5% after hours on the news from the FDA to trade near $12 apiece. The company said in a response that its "reviewing the request and is evaluating the full range of potential options."
The decision follows a meeting of the FDA's Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees, which convened on March 13 and 14, 2017. This committee voted 18 to eight (with one abstention) that the benefits of the reformulated 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 recently appointed FDA Commissioner Scott Gottlieb. The move is one of Gottlieb's first in the new top spot at the agency.
The review of the post-marketing data showed that injection abuse of reformulated Opana ER, which has been increasing, has been linked with a serious outbreak of HIV and hepatitis C, and incidences of thrombotic microangiopathy, where blood clots form in small vessels.
"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market," said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. "This action will protect the public from further potential for misuse and abuse of this product."
The FDA is waiting to hear Endo Pharmaceuticals' decision, and in the meantime, has spread the word to healthcare professionals about the risks linked to abuse of Opana ER. If the company does not voluntarily withdraw the product, the regulatory authority can force the issue by withdrawing approval.
Endo International, the parent company of Endo Pharmaceuticals, made the fairly non-committal statement on Thursday: "Endo International is aware of today's announcement by the FDA requesting that Endo voluntarily withdraw Opana ER from the market. Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward."
Endo tried to emphasize that the drug is safe and effective "when taken as prescribed." It has not been a good year for the Irish drugmaker. The pain management company ousted its CEO Rajiv de Silva last September amidst continued backlash to close peer Valeant Pharmaceuticals—de Silva was the president of Valeant previously and mentored under beleaguered CEO Mike Pearson. Amid the opioid crisis, the company has been eliminating jobs, with multiple rounds of layoffs. Opana ER only brought in $159,000 in U.S. sales in 2016, down from $198,000 in 2014.
Ohio Attorney General Mike DeWine has filed a lawsuit against five leading prescription opioid manufacturers, including Endo Health Solutions, for fraudulent marketing that he alleges has fueled the opioid epidemic. Opioid abuse is a massive and growing problem in the U.S. Companies are taking a variety of approaches to its prevention. These range from reformulation to packaging, for example TimerCap's pill bottle lids that show the time since the last dose can alert family members to abuse within the household.