FDA Approves More Powerful, Pure Hydrocodone Drug - KSWO 7News | Breaking News, Weather and Sports

FDA Approves More Powerful, Pure Hydrocodone Drug

By MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) - 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 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 comes 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.

The FDA announcement also comes just one day after the agency 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.

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.

Shares of San Diego-based Zogenix Inc. jumped in trading Friday, climbing 85 cents, or 37.9 percent, to $3.09. Earlier shares set a 52-week high of $3.45.

Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

  • Local NewsNewsMore>>

  • AT&T, Time Warner close $81B merger 2 days after judge OKs

    AT&T, Time Warner close $81B merger 2 days after judge OKs

    Thursday, June 14 2018 9:38 PM EDT2018-06-15 01:38:05 GMT
    Monday, June 18 2018 5:24 AM EDT2018-06-18 09:24:24 GMT
    (AP Photo/Richard Drew, File). FILE - In this Wednesday, June 13, 2018, file photo, the logos for Time Warner and AT&T appear above alternate trading posts on the floor of the New York Stock Exchange. A federal judge has approved the $85 billion me...(AP Photo/Richard Drew, File). FILE - In this Wednesday, June 13, 2018, file photo, the logos for Time Warner and AT&T appear above alternate trading posts on the floor of the New York Stock Exchange. A federal judge has approved the $85 billion me...

    AT&T and Time Warner have completed their merger, one of the biggest media deals ever, just two days after a federal judge approved the combination over objections by the Trump Justice Department that it would hurt...

    AT&T and Time Warner have completed their merger, one of the biggest media deals ever, just two days after a federal judge approved the combination over objections by the Trump Justice Department that it would hurt consumers.

  • California moves to clear coffee of cancer-risk stigma

    California moves to clear coffee of cancer-risk stigma

    Saturday, June 16 2018 1:38 AM EDT2018-06-16 05:38:55 GMT
    Monday, June 18 2018 5:22 AM EDT2018-06-18 09:22:53 GMT
    (AP Photo/Richard Vogel, File). FILE - In this Sept. 22, 2017, file photo, a barista pours steamed milk into a cup of coffee at a cafe in Los Angeles. State health officials proposed a regulation change Friday, June 15, 2018, that would declare coffee ...(AP Photo/Richard Vogel, File). FILE - In this Sept. 22, 2017, file photo, a barista pours steamed milk into a cup of coffee at a cafe in Los Angeles. State health officials proposed a regulation change Friday, June 15, 2018, that would declare coffee ...

    California officials, having concluded coffee drinking is not a risky pastime, are proposing a regulation that will essentially tell consumers of America's favorite beverage they can drink up without fear.

    California officials, having concluded coffee drinking is not a risky pastime, are proposing a regulation that will essentially tell consumers of America's favorite beverage they can drink up without fear.

  • Pope: Abortion is 'white glove' equivalent to Nazi crimes

    Pope: Abortion is 'white glove' equivalent to Nazi crimes

    Saturday, June 16 2018 10:59 AM EDT2018-06-16 14:59:00 GMT
    Monday, June 18 2018 5:22 AM EDT2018-06-18 09:22:48 GMT
    (AP Photo/Alessandra Tarantino). Pope Francis greets members of an association of people honored by the Italian Presidency for their commitment to their work, in the Paul VI Hall at the Vatican, Friday, June 15, 2018.(AP Photo/Alessandra Tarantino). Pope Francis greets members of an association of people honored by the Italian Presidency for their commitment to their work, in the Paul VI Hall at the Vatican, Friday, June 15, 2018.

    Pope Francis has denounced abortion as the "white glove" equivalent of the Nazi-era eugenics program and urged families to accept the children God gives them.

    Pope Francis has denounced abortion as the "white glove" equivalent of the Nazi-era eugenics program and urged families to accept the children God gives them.

Powered by Frankly