Other Views: The FDA makes a move on opioids

FDA asks drugmaker to stop selling its opioid painkiller

Opioid abuse is a national epidemic and for the first time the Food and Drug Administration is asking a drug company to take its product off the shelves.

It's the first time the FDA has asked for the removal of an opioid painkiller.

"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 Dr. Scott Gottlieb in a statement.

Endo said in a statement that it is reviewing the FDA's request and will "Determine the appropriate path forward".

In an issue paper released Tuesday, the FDA's Center for Drug Evaluation and Research said that determining the impact of abuse-deterrent formulations is difficult because numerous drugs are being taken illicitly, so comprehensive and reliable data can be hard to come by.

Opana ER is prescribed about 50,000 times a month and Endo has to be mindful of the needs of those patients who are using the pill as intended, Campanelli said Tuesday during a presentation at the Goldman Sachs Healthcare Conference. When the company submitted its reformulated version to the FDA in 2012, the agency decided the data weren't strong enough to show that it could "meaningfully reduce abuse", and the agency denied a request to include a label that would describe its reformulation as having abuse-deterrent properties. The agency found that the benefits of the medication, Opana ER, were outweighed by its risks: It is frequently snorted and injected, and linked to HIV outbreaks, the spread of hepatitis C, and a blood clotting disorder called thrombotic microangiopathy.

An FDA market review prompted the decision. "This action will protect the public from further potential for misuse and abuse of this product".

As word of the FDA request circulated, shares of Endo International dipped nearly 13% to $11.99 on Thursday. It will also continue to evaluate and examine all approved opioid pain medicines. In 2012, Endo released a newly formulated version meant to make the drug resistant to abuse by snorting or injecting.

Thursday's announcement followed a March vote from an independent group of experts, brought together by the FDA, who voted 18-8 that the benefits of reformulation no longer outweighed the risks.

Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns".

Opioids continue to ruin lives, and end them, in Maryland.

The drug was previously reformulated to help prevent abuse. The Centers for Disease Control and Prevention says that 91 people now die every day from opioid overdose, a figure that has been driven by a more than four-fold increase in the number of fatalities from prescription opioids since 1999.

Related:

Comments


Other news