The Food and Drug Administration is still reviewing King Pharmaceuticals Inc.'s pain drug candidate Embeda, King said Wednesday.
An FDA ruling on Embeda, a morphine pill that is designed to be abuse-resistant, was due Tuesday. King said it is in discussions with the agency and suggested the review will last through early 2009.
Embeda capsules contain an extended-release dose of morphine and a core of naltrexone, a drug that is used to combat addiction. King said that if the pill is crushed or chewed, rather than swallowed as intended, the naltrexone will be released, canceling out the high of the morphine.
Pain pills are often abused by users who grind them up to snort or inject.
In November, an FDA panel said Embeda might help deter abuse, but indicated it was not a major improvement on older drugs. The panel also said there were potential safety issues with exposing patients to naltrexone.
Remoxy contains oxycodone in a viscuous form, which is designed to frustrate attempts defeat to its time-release formula by crushing, snorting or dissolving the drug in alcohol.
Oxycodone is marketed by Purdue Pharma as OxyContin.
King Pharmaceuticals shares fell 2 cents to $10.39 in morning trading.
