Nucynta Gets Nod from FDA - Drug Discovery and Development

Johnson & Johnson said the Food and Drug Administration has approved an extended-release version of the painkiller Nucynta.

The New Brunswick, N.J., conglomerate said Nucynta is an oral medication taken twice daily to manage moderate-to-severe chronic pain in adults.

The immediate-release version of the drug was approved in 2008 and is sold as a treatment for severe acute pain in patients 18 and older.

Last October, J&J said the FDA had requested additional information on the conversion of the extended-release formulation used in prior studies to a version that is designed to increase resistance to breaking or crushing. Nucynta is an opioid and listed as a schedule II drug, meaning it has a high potential for abuse, and users may become psychologically or physically dependent on the drug.

Crushing an opioid often makes it easier to abuse, and there has been a movement in the pharmaceutical industry to make more abuse-resistant opioids.

Janssen Pharmaceuticals Inc., a J&J company, developed Nucynta with Grunenthal GmbH, a privately-held German drug company that discovered the compound.

Date: August 26, 2011
Source: Associated Press