J&J Gets FDA Request For More Info On Pain Drug
From Associated Press (October 4, 2010)
NEW YORK -- Johnson & Johnson said Monday the Food and Drug Administration requested additional information on the company’s extended release version of Nucynta.
The immediate-release version of the drug is already sold as a treatment for severe acute pain in patients 18 and older.
J&J said the FDA requested data regarding the conversion of the extended release formulation used in prior studies to an extended release 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.
The FDA has not asked for new studies.
Shares of J&J fell 24 cents to $61.51 in afternoon trading.
Posted: October 2010