Breaking News Bar
updated: 10/25/2013 5:10 PM

FDA approves more powerful, pure hydrocodone drug

hello
Success - Article sent! close
  • Associated Press/Feb. 19, 2013Hydrocodone bitartrate and acetaminophen pills, also known as Vicodin, are arranged for a photo at a pharmacy in Montpelier, Vt.

      Associated Press/Feb. 19, 2013Hydrocodone bitartrate and acetaminophen pills, also known as Vicodin, are arranged for a photo at a pharmacy in Montpelier, Vt.

 
Associated Press

WASHINGTON -- The Food and Drug Administration has approved a stronger, single-ingredient version of the painkiller hydrocodone, the widely-abused prescription medicine for chronic pain.

The agency said Friday it approved the pill Zohydro for patients with pain that requires "daily, around-the-clock, long-term treatment" that cannot be addressed with other drugs.

Hydrocodone is currently sold in combination pills like Vicodin to treat pain from injuries, surgery, arthritis, migraines and other ailments. The new drug from Zogenix is the first pure, non-combination form of the drug approved in the U.S.

The approval came as a surprise since the agency's own panel of outside advisers gave the drug an overwhelmingly negative review last year. The agency's panel of pain specialists voted 11-2, with one abstention, against approving the drug last December, questioning the need for a new form of one of most widely-abused prescription painkillers in U.S.

Zohydro's approval was quickly criticized by patient safety advocates who had urged the FDA to reject the drug at a public meeting last year.

"We're just going to kill more kids and then the FDA is going to come back and say, `oh, we made a mistake,"' said Avi Israel of Buffalo, N.Y. Israel's son Michael committed suicide in 2011 while struggling with painkiller addiction. Israel is the founder of a group called, Save the Michaels of the World, which aims to combat painkiller abuse in young people.

In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures. Hydrocodone pills also consistently rank among most-abused medicines in the U.S., according to the DEA.

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

Friday's news was also blasted by lawmakers on Capitol Hill who have been trying to rein in prescription drug abuse in their home states.

Rep. Bill Keating, D-Mass., said the FDA should have required the drug to contain anti-abuse design features that would make it harder for users to crush the pills and snort or inject them.

"FDA not only approves this dangerous drug, but does so without requiring any abuse-deterrent features. This is outrageous," Keating said in a statement. "Abuse-deterrent technologies should not be the anomaly, they must be the norm."

In recent years, Purdue Pharma, Pfizer Inc., Endo Health Solutions Inc. and other drugmakers have developed tamper-resistant versions of popular opioid drugs.

The timing of the FDA announcement also drew criticism from safety advocates and lawmakers. Only one day earlier the FDA said it would support stronger restrictions on combination drugs containing hydrocodone, including Vicodin and dozens of other generic formulations.

The drugs currently available mix hydrocodone with non-addictive pain relievers like aspirin and acetaminophen. For decades these drugs have been subject to less rigorous prescribing limits than other prescription painkillers like oxycodone.

Late Thursday, the FDA said it would recommend moving hydrocodone drugs from the schedule III class to the schedule II class of medications, a move that will limit the number of refills patients can receive and how many health professionals can prescribe the drugs.

The Drug Enforcement Administration had first asked the agency to take that step a decade ago, and lawmakers and safety advocates had increased their pressure on the agency in recent years.

Shares of San Diego-based Zogenix, Inc. jumped in trading Friday, climbing 80 cents, or 36 percent, to $3.04. Earlier shares set a 52-week high of $3.45.

Share

Interested in reusing this article?

Custom reprints are a powerful and strategic way to share your article with customers, employees and prospects.

The YGS Group provides digital and printed reprint services for Daily Herald. Complete the form to the right and a reprint consultant will contact you to discuss how you can reuse this article.

Need more information about reprints? Visit our Reprints Section for more details.

Contact information ( * required )

Name * Company Telephone * E-mail *

Message (optional)

Success - Reprint request sent Click to close
Comments ()
Guidelines: Keep it civil and on topic; no profanity, vulgarity, slurs or personal attacks. People who harass others or joke about tragedies will be blocked. If a comment violates these standards or our terms of service, click the X in the upper right corner of the comment box. To find our more, read our FAQ.
    help here