FDA blocks generic OxyContin, fearing abuse - WSLS 10 NBC in Roanoke/Lynchburg Va

FDA blocks generic OxyContin, fearing abuse

Posted: Updated:

MATTHEW PERRONE
AP Health Writer


WASHINGTON (AP) - Federal health regulators will require generic versions of the best-selling painkiller OxyContin to include recent formulation changes designed to make the pill harder to abuse.

The Food and Drug Administration said late Tuesday it would not approve any generic versions of OxyContin based on the original formulation because it "poses an increased potential for certain types of abuse."

The FDA decision is a key victory for Purdue Pharma LP, which spent years developing a tamper-resistant version of the blockbuster pain pill. The company's patent on original OxyContin expires Tuesday. Normally such expirations open the door to a slew of cheaper versions from generic drug manufacturers. However, the FDA decision effectively protects Purdue from lower-price competition by requiring generic companies to develop their own abuse-deterrent designs.

OxyContin has long been one the nation's top-selling prescription painkillers with sales of more than $2.8 billion last year, according to prescription tracker IMS Health. A time-release version of the narcotic oxycodone, the pill was hailed as a breakthrough treatment for chronic pain when it was approved in late 1995. The long-acting formula could be used over 12 hours to maintain a steady level of oxycodone in patients suffering from moderate to severe pain.

But drug abusers quickly discovered they could get a heroin-like high by crushing the pills and snorting or injecting the entire dose at once.

In 2007, Purdue Pharma and three of its executives paid $634 million and pled guilty to charges of misleading the public about the safety and addictiveness of OxyContin.

In April 2010 Purdue introduced a new version of the drug designed to be more difficult to crush, break or dissolve. On Tuesday the FDA said it would update the drug's labeling to reflect recent studies supporting those claims.

"While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin," said Douglas Throckmorton, FDA deputy director, in a release.

The agency said it based its decision on medical studies of OxyContin, reports of abuse and misuse, public comments and petitions.

Stamford, Conn.-based Purdue said in a statement that the new labeling will provide "important information to health care professionals."

The decision was praised by members of Congress who have worked to curb prescription drug abuse.

"We are in the midst of a prescription drug abuse epidemic, and by requiring anti-abuse mechanisms be included in generic versions of OxyContin, the FDA has prevented the floodgates from being opened further," said Sen. Charles Schumer, D-N.Y., in an emailed statement.

  • Most Popular StoriesMost Popular StoriesMore>>

  • April Mugshots

    April Mugshots

    Tuesday, April 22 2014 2:42 PM EDT2014-04-22 18:42:32 GMT
    Thomas Allen WinstonThomas Allen Winston
    The following are mugshots and charges of individuals arrested between April 1-4 by the Sullivan County Sheriff's Office.
    The following are mugshots and charges of individuals arrested between April 1-4 by the Sullivan County Sheriff's Office.
  • 12-year-old accidentally kills little brother in Franklin Co.

    12-year-old accidentally kills little brother in Franklin Co.

    Tuesday, April 22 2014 6:24 PM EDT2014-04-22 22:24:35 GMT
    The Franklin County Sheriff's Office says a 12-year-old year boy accidentally killed his 7-year-old brother. Deputies received a 911 call about shots fired on Tuesday, April 21 stat 11:46 a.m.
    The Franklin County Sheriff's Office says a 12-year-old year boy accidentally killed his 7-year-old brother. Deputies received a 911 call about shots fired on Tuesday at 11:46 a.m.
  • Roanoke Mother stands up against bullying after son's suicide

    Roanoke Mother stands up against bullying after son's suicide

    Tuesday, April 22 2014 6:05 PM EDT2014-04-22 22:05:18 GMT
    A Roanoke County mother is standing up against bullying after her 16-year-old son committed suicide. Maxx Poff was found dead on February 20th from a gunshot wound. "Maxx was a lover. He wasn't a fighter and it just kills me to know the pain he was going through for somebody bullying him," Maxx's mother Dianna Poff says. Roanoke County Assistant Police Chief Chuck Mason says detectives heard information was being circulated through social media that suggested bullying was the mean reason fo...
    A Roanoke County mother is standing up against bullying after her 16-year-old son committed suicide. Maxx Poff was found dead on February 20th from a gunshot wound. "Maxx was a lover. He wasn't a fighter and it just kills me to know the pain he was going through for somebody bullying him," Maxx's mother Dianna Poff says. Roanoke County Assistant Police Chief Chuck Mason says detectives heard information was being circulated through social media that suggested bullying was the mean reason fo...
  • Fire at Saw Mill in Bedford County is under investigation

    Fire at Saw Mill in Bedford County is under investigation

    Wednesday, April 23 2014 9:55 PM EDT2014-04-24 01:55:50 GMT
    A fire ata saw mill in Bedford County is under investigation. It happened thisafternoon around 5 at Central Virginia Pallet and Stake on Centerville Road.Bedford County's Fire Chief says there were no injuries, but the owner estimates the damages at about $75,000The chief says thefire is still burning, and it will likely burn for a few days, but it is contained.The cause of the fire is unknown, butit's believed to be accidental.
    A fire ata saw mill in Bedford County is under investigation. It happened thisafternoon around 5 at Central Virginia Pallet and Stake on Centerville Road.Bedford County's Fire Chief says there were no injuries, but the owner estimates the damages at about $75,000The chief says thefire is still burning, and it will likely burn for a few days, but it is contained.The cause of the fire is unknown, butit's believed to be accidental.
  • 29 Virginia High Schools on Personal Finance Top-100 List

    29 Virginia High Schools on Personal Finance Top-100 List

    Tuesday, April 22 2014 9:32 PM EDT2014-04-23 01:32:06 GMT
    29 schools in the Commonwealth, including many in our area, ranked the the nation's top 100 best high schools for personal finance instruction.
    29 schools in the Commonwealth, including many in our area, ranked the the nation's top 100 best high schools for personal finance instruction.
  • Franklin Co. Sheriff's Office investigating juvenile death

    Franklin Co. Sheriff's Office investigating juvenile death

    Franklin Co. Sheriff's Office investigating juvenile death

    Tuesday, April 22 2014 10:50 AM EDT2014-04-22 14:50:58 GMT
    Deputies were called to Double Oaks Lane in the Burnt Chimney community, where they found a seven-year-old boy with a gunshot wound.
    Deputies were called to Double Oaks Lane in the Burnt Chimney community, where they found a seven-year-old boy with a gunshot wound.
Powered by WorldNow

WSLS 10, P.O. Box 10
Roanoke, VA 24022-0010

Telephone: 540.981.9110
Fax: 540.343.3157
Email: news@wsls.com

Can't find something?
Powered by WorldNow
All content © Copyright 2000 - 2014 Media General Communications Holdings, LLC. A Media General Company.