US panel opposes pure hydrocodone painkiller

by Matthew Perrone

(AP)—U.S. government health experts overwhelmingly voted against a stronger version of hydrocodone on Friday, questioning the need for a new form of one of most widely abused prescription painkillers.

The 's panel of pain specialists voted 11-2 with one abstention against Zohydro for moderate to severe chronic pain. The drug was developed as a long-acting by San Diego-based Zogenix Inc.

The FDA is not required to follow the group's recommendation, though it often does so. It is scheduled to make its decision on the drug by March 1.

The panelists acknowledged that the pill would likely reduce pain, but worried it would exacerbate the U.S. epidemic of prescription painkiller abuse.

"I think the sponsor fulfilled the expectations of FDA, however I think the entire class is problematic in terms of abuse and safety issues," said Professor James Ware of the Harvard School of Public Health.

If approved, Zohydro would be the first pure hydrocodone medication available in the U.S. Currently available products combine the drug with lower-grade painkillers such as acetaminophen.

Hydrocodone is prescribed to treat pain from injuries, surgery, arthritis, migraines and a variety of other ailments.

Hydrocodone-containing pills consistently rank as the first or second most-abused medicines in the U.S., according to the Drug Enforcement Administration.

The drug belongs to a family of medicines known as opiates or because they are chemically similar to opium. They include morphine, heroin, , codeine, methadone and .

block pain but also unleash intense feelings of well-being and can create physical dependence. Several panelists said the risks of fatal overdose with opioids swayed their vote against Zohydro.

In 2011, the U.S. Centers for Disease Control estimated 14,800 deaths were related to opioids.

Zogenix has touted the benefits of its long-lasting pill, which only needs to be taken once every 12 hours, compared with every four to six hours for combination drugs like Vicodin. The company also notes that patients taking pure hydrocodone would not be at risk for acetaminophen-related liver side effects.

In recent years the FDA has begun prodding drugmakers to develop more sophisticated pain relievers that are harder to abuse, but such measures are not a requirement.

Shares of San Diego-based Zogenix were halted ahead of the meeting and last traded at $2.36.

5 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

New powerful painkiller has abuse experts worried

Dec 26, 2011

Drug companies are working to develop a pure, more powerful version of the nation's second most-abused medicine, which has addiction experts worried that it could spur a new wave of abuse.

Senator warns FDA on danger of newest painkillers

Jan 08, 2012

Following fatal shootings in two New York pharmacy robberies, a U.S. senator is warning that a new batch of "super painkillers" now under review could force repeats of recent violent robberies that left six people dead.

FDA cracks down on hydrocone products

Sep 29, 2007

The U.S. Food and Drug Administration says it will start taking enforcement action against companies marketing unapproved hydrocodone products.

FDA orders lower doses in prescription painkillers

Jan 13, 2011

(AP) -- Federal health regulators are limiting a key ingredient found in Vicodin, Percocet and other prescription painkillers that have been linked to thousands of cases of liver damage each year.

Recommended for you

WHO: Millions of Ebola vaccine doses ready in 2015

10 hours ago

The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines will start being tested in March.

Added benefit of vedolizumab is not proven

Oct 23, 2014

Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the ...

Seaweed menace may yield new medicines

Oct 22, 2014

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

User comments