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>>

  • Vigil held for 2-year-old girl who died after being left in hot van

    Vigil held for 2-year-old girl who died after being left in hot van

    Monday, September 1 2014 8:30 PM EDT2014-09-02 00:30:57 GMT
    Roanoke City Police are investigating the incident surrounding the death of a 2-year-old girl. According to a news release from police, officers were called to the 1500 block of Kenwood Boulevard SE at 4:27 p.m. Sunday for an unresponsive child.
    Roanoke City Police are investigating the incident surrounding the death of a 2-year-old girl. According to a news release from police, officers were called to the 1500 block of Kenwood Boulevard SE at 4:27 p.m. Sunday for an unresponsive child.
  • Kraft Foods recalls over 7,500 cases of Kraft American Singles

    Kraft Foods recalls over 7,500 cases of Kraft American Singles

    Tuesday, September 2 2014 2:43 AM EDT2014-09-02 06:43:53 GMT
    (WSLS)-- Kraft Foods announces a voluntary recall of more than 7,500 cases of craft singles cheese slices.The company says the recall is a precaution after a supplier failed to store the cheese in accordance with Kraft temperature standards.No complaints or illnesses have been reported. If you have one of the affected packages, return it to the store where it was purchased for a full refund.Here are the affected items:Product Name:12 oz Kraft American Singles (16 slices)Best When Used by Date...
    (WSLS)-- Kraft Foods announces a voluntary recall of more than 7,500 cases of craft singles cheese slices.The company says the recall is a precaution after a supplier failed to store the cheese in accordance with Kraft temperature standards.No complaints or illnesses have been reported. If you have one of the affected packages, return it to the store where it was purchased for a full refund.Here are the affected items:Product Name:12 oz Kraft American Singles (16 slices)Best When Used by Date...
  • Community mourns loss of two-year-old girl left behind in hot car

    Community mourns loss of 2-year-old girl left behind in hot car

    Community mourns loss of 2-year-old girl left behind in hot car

    Monday, September 1 2014 9:50 PM EDT2014-09-02 01:50:01 GMT
    Dozens of people in the community in Southeast Roanoke gathered and circled around to remember the life of a two-year-old girl.
    Dozens of people in the community in Southeast Roanoke gathered and circled around to remember the life of a two-year-old girl.
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.