Maintenance. We are currently updating the site. Please check back shortly
Members login
  • TrustLaw
  • Members Portal
Subscribe

State AGs urge FDA to rethink approval of painkiller Zohydro

Source: Reuters - Thu, 12 Dec 2013 10:31 PM
Author: Reuters
hum-dis
Tweet Recommend Google + LinkedIn Bookmark Email Print
Leave us a comment

WASHINGTON, Dec 12 (Reuters) - Attorneys general from 28 U.S. states have asked the Food and Drug Administration to reconsider its approval of the powerful painkiller Zohydro ER, which Kentucky's top law enforcement official said could start an epidemic of abuse.

The drug, manufactured by Zogenix Inc of San Diego, was approved by the FDA in October.

In December 2012 a panel of outside experts convened by the agency had voted 11-2 against the drug's approval, citing its potential to cause addiction.

Kentucky Attorney General Jack Conway said his state had been hurt by abuse of prescription painkillers, especially OxyContin, and he feared more problems with Zohydro ER.

"The approval of this very potent drug is troubling because, unlike extended-release opioids containing abuse-deterrent properties, there is nothing that would prevent someone from easily crushing or injecting Zohydro ER to get high," Conway said.

Conway joined attorneys general from 27 states and the U.S. territory of Guam in signing a letter to FDA Commissioner Margaret Hamburg, dated Tuesday, asking that approval of Zohydro be reconsidered or that the drug be reformulated with chemical deterrents to abuse.

"State attorneys general do not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed," the letter said.

The attorneys general said Zohydro reportedly is five to 10 times more potent than standard hydrocodone products.

The FDA approved the drug for daily, long-term treatment for which other options were inadequate. FDA spokeswoman Morgan Liscinsky said the agency would review the attorneys generals' letter and respond.

Abuse of OxyContin became so widespread that manufacturer Purdue Pharma changed its formula in 2010 so that the drug could not be injected or snorted as easily.

Zogenix closed at $3.02 in U.S. trading on Thursday, up 0.6 percent.

We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of the Thomson Reuters Foundation. For more information see our Acceptable Use Policy.

comments powered by Disqus
TOPICAL CONTENT
Topical content
LATEST SLIDESHOW

Latest slideshow

See allSee all
FEATURED JOBS
Featured jobs