FDA: ‘limited’ benefit with tamper-proof OxyContin
Purdue Pharma LP, has promoted the new pill, plastic-like coating, which is designed to make the drug more difficult to crush and snort or inject.
Food and Drug Administration scientists said on Tuesday that the resistance of the abused drug is “limited” but “may provide an advantage over currently available OxyContin.”
A panel of FDA advisers said last year that the company needed to do more tests to demonstrate the manipulation of drug resistance.
The FDA will ask the same group on Thursday whether the drug should be approved based on new data presented by Stamford, Connecticut-based Purdue Pharma.
OxyContin, the nation-counter pain reliever last year, with sales of over $ 2 billion, was hailed as a breakthrough for the treatment of severe chronic pain when introduced in 1996. A time release version of oxycodone drug, which was designed for use over 12 hours to maintain an equilibrium state of the painkiller in the bodies of seriously ill patients.
However, OxyContin and similar drugs have quickly adapted to the drug, they discovered they could get a heroine like high by crushing the tablets and injection or inhalation of the dose at once.
A federal survey conducted in 2007 revealed that 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.
The FDA has made a series of public service announcements about the problem with little success, and more recently, began pressuring the companies to do to ease the pain more difficult to abuse.
In August, King Pharmaceutical pharmaceutical Embed became the first analgesic to obtain approval from the FDA as a tamper-proof medicine.
When Purdue Pharma went before the FDA panel last year, the company said it plans to offer trial versions of manipulations of the lowest dose of OxyContin, maintaining the highest doses in their original form.
The FDA panel said it was a bad idea because doctors and doctors may mistakenly assume that all doses had been reformulated.
The company has already said he will not change at all doses of the drug.
The documents published online, Purdue Pharma acknowledged that no statement would “prevent all methods of manipulation that can lead to abuse.” But the company says the new version should significantly discourage abuse of the pills making it harder and more time to manipulate.
OxyContin was the best selling painkiller in the U.S. last year with sales of nearly $ 2.3 billion, according to medical research company IMS Health. The drug accounts for the market for more than half of pharmaceuticals derived from codeine, which also includes several generic drug Vicodin.