FDA calls for withdrawal of opioid product for first time in history
pharmafile | June 9, 2017 | News story | Medical Communications | Endo pharmaceuticals, FDA, Scott Gottlieb
The FDA, since the appointment of Scott Gottlieb as commissioner, has made strong noises about tackling the opioid crisis and has now followed this up with strong action. For the first time in the agency’s history, it has asked for the withdrawal of Endo Pharmaceutical’s opioid painkiller from the market due to the risk of abuse.
The decision comes after opioid overdoses have quadrupled in the US since 1999, with 33,000 deaths from overdoses in 2015. The crisis has led to multiple states and cities launching lawsuits against the pharmaceutical companies producing the painkillers, most often over the method of marketing the products.
Any withdrawal of its drug will be a decision that depends on Endo, it can choose whether to comply with the request or not. It could submit a case to re-evaluate the safety of the product and could possibly take legal action to fight any removal from the market.
Opana ER is the painkiller in question, a drug that was actually reformulated to make it more difficult to abuse in 2012. The drug had previously been found to be abused crushing pills to abuse the painkiller nasally. Once reformulated the drug then began to have an alternative misuse problem, as those seeking to abuse the drug were being discovered to inject the drug.
In certain states, this led to rising occurrences of issues related intravenous needle sharing, such as HIV and hepatitis C. Beyond this, heroin use began to increase in areas as users began to seek alternatives.
“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, M.D. “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.”
It is not yet known how far this new push will see the agency go, as speculation emerges that the FDA may request other similar drugs to be removed from the market.
The result of this initial action has seen the share price of Endo plunge by 12%. For its own part, the company responded to the news in a statement: “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 favourable risk-benefit profile when used as intended in appropriate patients.”
Ben Hargreaves
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