FDA advisory panel votes against approval of DMD drugIn the war on this country’s opioid epidemic, physicians deemed “super-prescribers” have come under fire for dispensing opioids for long-term use when a medical situation warrants a shorter course, or for refilling prescriptions for patients who may be struggling with substance use disorder, for example. The Food and Drug Administration (FDA) has just set its sights on a new enemy, though: the opioid itself.

Opana ER (oxymorphone hydrochloride) is a powerful prescription that has enjoyed FDA approval. However, the agency has asked the drug maker, Endo Pharmaceuticals, to pull the product from the market. If Endo fails to comply with the request, the FDA has said it will mandate the action “by withdrawing approval.”

New FDA commissioner puts opioid crisis at the top of his list

The Centers for Disease Control and Prevention (CDC) estimates that in 2015 alone, opioid misuse cost 33,000 people their lives, and, further, the plague is ongoing, with 91 opioid-related U.S. fatalities every day. The FDA’s new commissioner, Scott Gottlieb, said in a statement last month that his “highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction.”

Gottlieb went on to say that “[w]hile there has been a lot of good work done by FDA to date, and many people are working hard on this problem, I have asked my FDA colleagues to see what additional, more forceful steps we might take.”

Going head-to-head with a drug already on the market may be one of the forceful steps Gottlieb had in mind.

Powerful opioid subject to abuse; manufacturer “remains confident”

Opana ER is an extended-release opioid marketed to patients that require pain medicine long-term; when taken as directed, its pain relief can last for 12 hours, which sets it apart from many other drugs in its class. However, when taken improperly — as in intravenously — the extended release benefit is lost (rather, the brain is flooded with an intensely concentrated dose all at once), and worse still, can culminate in severe crisis or tragedy.

The FDA reports that outbreak of serious disease has been traced back to Opana ER abuse: opioid-addicted individuals have been known to crush the pill and then inject it, which has led to the sharing of contaminated needles and the spread of blood-borne infections like HIV and Hepatitis C (for instance, an HIV outbreak in Indiana two years ago).

The drug maker’s response to the FDA announcement was posted on its website:

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

Despite its faith in its product when used as prescribed, however, Endo may essentially have no choice in clinging to the market in this instance if the FDA makes good on its promise to pull its approval should the drug maker ignore this initial request.

Independent panel weighs in, Opana ER loses

The risk of Opana ER abuse is not news to Endo — five years ago the pharmaceutical company reformulated the drug in an attempt to make it impervious to crushing. That step failed to appease the FDA. Earlier this year, the agency held an advisory committee meeting where independent experts decided that the dangers associated with Opana ER were still unacceptably high. The panel vote was 18-8 in favor of getting the drug off America’s pharmacy shelves.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, had this to say in the agency’s announcement: “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. This action will protect the public from further potential for misuse and abuse of this product.”

And in case there’s any doubt as to whether Opana ER is a mere outlier when it comes to FDA scrutiny, the agency’s announcement concludes with this word of caution:

“The FDA will continue to examine the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of our response to this public health crisis.”


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