Personal Injury Law

OxyContin Maker Says New Formula Offers Less Chance of Abuse

By Jane Akre

OxyContin

The maker of the painkiller, OxyContin has applied to the Food and Drug Administration to reformulate the pill to reduce the chances of misuse or abuse.

Purdue Pharma LP wants the drug to be tamper-resistant so it's harder to crush and dissolve in water. The active drug would be released as a gel making it harder to inject, according the FDA staff reporting on the agency's Web site.

Drug abusers typically dissolve or crush the drug and put it in water to inject it for a heroin-like effect.

Two years ago, the company had to pay $635 million to settle federal charges that it underplayed the drug's potential for abuse. Addiction rates are reported to be between 1 and 13 percent.

Purdue is in a race with King Pharmaceuticals Inc, which is reformulating oxycodone, the active drug in OxyContin. Outside advisors will meet on the application Thursday.

Last year the FDA refused a request to reformulate OxyContin, saying there was not enough information on the new version. This time around Purdue will leave out information about the tamper-resistant qualities in the product's label, reports the Wall Street Journal.

OxyContin was approved by the FDA in 1995 to treat chronic pain. Radio host, Rush Limbaugh admitted an addiction to the drug in 2003, and sought treatment, narrowly averting felony charges for doctor shopping.

If approved, Purdue, of Stamford, Conn. will replace existing supplies with the new OxyContin-TR formula.

A report issued last year,  Monitoring the Future: National Results on Adolescent Drug Use, finds that marijuana and alcohol use has declined while the abuse of painkillers such as Vicodin and Oxycontin has increased among teens.

Much of the drug use among the young is seen in white middle-class families.  #

Full post as published by InjuryBoard on September 23, 2009 (boomark / email).