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>>

  • Prostitution sting nets 31 arrests

    Prostitution sting nets 31 arrests

    Tuesday, April 20 2010 11:21 PM EDT2010-04-21 03:21:00 GMT
    31 people are in trouble with the law after a three day prostitution sting in Richmond. Police told NBC12 they targeted specific areas where residents and business owners complained about the illegal activity.
  • Fugitive sex offender captured in Roanoke

    Fugitive sex offender captured in Roanoke

    Fugitive sex offender captured in Roanoke

    Wednesday, July 30 2014 12:41 AM EDT2014-07-30 04:41:44 GMT
    ROANOKE (WSLS) - A man wanted for sex crimes against a minor was captured in Roanoke during a traffic stop.
    ROANOKE (WSLS) - A man wanted for sex crimes against a minor was captured in Roanoke during a traffic stop.
  • Bedford Sheriff Department searches home on Nemmo Road

    Bedford Sheriff Department searches home on Nemmo Road

    Tuesday, July 29 2014 4:19 PM EDT2014-07-29 20:19:56 GMT
    There was a flurry of police activity Monday in Bedford County.
    There was a flurry of police activity Monday in Bedford County.
  • Franklin County accident causes lane closures on Brooks Mill Road

    Franklin County accident causes lane closures on Brooks Mill Road

    Franklin County accident causes lane closures on Brooks Mill Road

    Wednesday, July 30 2014 5:16 AM EDT2014-07-30 09:16:44 GMT
    FRANKLIN COUNTY (WSLS) - State Police are on the scene of an accident on Brooks Mill Road (Rt. 834) near the Ponderosa campground.
    FRANKLIN COUNTY (WSLS) - State Police are on the scene of an accident on Brooks Mill Road (Rt. 834) near the Ponderosa campground.
  • Fugitive sex offender captured in Roanoke

    Fugitive sex offender captured in Roanoke

    Fugitive sex offender captured in Roanoke

    Wednesday, July 30 2014 12:41 AM EDT2014-07-30 04:41:44 GMT
    ROANOKE (WSLS) - A man wanted for sex crimes against a minor was captured in Roanoke during a traffic stop.
    ROANOKE (WSLS) - A man wanted for sex crimes against a minor was captured in Roanoke during a traffic stop.
  • Roanoke Police investigate shots fired incident

    Roanoke Police investigate shots fired incident

    Tuesday, July 29 2014 10:37 PM EDT2014-07-30 02:37:03 GMT
    On July 29, 2014 at 6:08 p.m. Roanoke Police were dispatched to the 1200 block of Orange Avenue NE to investigate a shots fired call. Immediately upon arrival officers detained several subjects believed to have been involved in the incident. The preliminary investigation suggests the individuals involved were traveling in two different vehicles on Hollins Road when at least one of the occupants in one of the vehicles starting shooting at the other vehicle. The vehicles separated briefly and t...
    On July 29, 2014 at 6:08 p.m. Roanoke Police were dispatched to the 1200 block of Orange Avenue NE to investigate a shots fired call. Immediately upon arrival officers detained several subjects believed to have been involved in the incident. The preliminary investigation suggests the individuals involved were traveling in two different vehicles on Hollins Road when at least one of the occupants in one of the vehicles starting shooting at the other vehicle. The vehicles separated briefly and t...
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.