Zohydro Sales Banned in Massachusetts

The pure hydrocodone drug Zohydro ER (extended release) will be banned in Massachusetts, Governor Deval Patrick has announced. He cited a public health emergency stemming from opioid abuse, Reuters reports.

“The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large,” Governor Patrick said in a news release.

Zohydro is designed to be released over time, and can be crushed and snorted by people seeking a strong, quick high. It was approved for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. Other hydrocodone drugs on the market, such as Vicodin, also contain acetaminophen.

In a statement, Zogenix said, “We believe Governor Patrick’s ban on Zohydro ER only serves to unfairly restrict patient access to the only hydrocodone pain reliever available for long-term, daily, severe chronic pain patients who are obtaining relief with short-acting hydrocodone combination products, but who are at risk for potentially fatal liver toxicity due to their daily intake of acetaminophen. Ultimately, the ban on the prescription medication will add to patient suffering in the state.”

In December 2012, a panel of experts assembled by the Food and Drug Administration (FDA) voted against recommending approval of Zohydro ER. The panel cited concerns over the potential for addiction. In the 11-2 vote against approval, the panel said that while Zogenix had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including oxycodone.

Last week, Zohydro’s manufacturer, Zogenix, announced it will assemble an oversight board designed to spot misuse of the drug.

The FDA’s decision to approve Zohydro has been criticized by some legislators and public health groups. FDA Commissioner Margaret Hamburg has received letters protesting the decision from 28 state attorneys general and four senators, among others. Law enforcement agencies and addiction experts predict approval of the drug will lead to an increase in overdose deaths.