BRISTOL — King Pharmaceuticals Inc. said Thursday the Food and Drug Administration approved its drug Embeda, a painkiller that is designed to be abuse-resistant.
The FDA approval covers the use of Embeda for moderate to severe chronic pain. Embeda’s primary ingredient is morphine, but the pills contain a core of a second drug called naltrexone. If the pill is taken normally, it will release the morphine. However if it is crushed or chewed, the naltrexone is released, canceling out the high from the morphine.
“We are focused on developing medicines that use novel technologies designed to reduce drug liking and make it more difficult to extract the active ingredient,” King CEO Brian Markison said.
King said it will launch Embeda in September. The company acquired the rights to Embeda at the end of 2008, when it bought the drug’s developer Alpharma Inc. for $1.6 billion.
Just how effective Embeda will be in helping fight prescription drug abuse remains uncertain, even according to a King press release, which states:
The clinical significance of the degree of this reduction has not been established, and there is no evidence that the naltrexone in Embeda reduces the abuse liability of Embeda.”
In aftermarket trading, King shares rose 42 cents, or 4 percent, to $11. The stock advanced 4.4 percent to $10.58 during the day.
King is developing a second pain drug called Remoxy. That drug is designed to resist abuse because its main ingredient, oxycodone, is in a thick liquid form. King asked the FDA to approve the drug in December, but the agency requested more data. King plans to resubmit its application in the middle of 2010.
Oxycodone is the active ingredient in OxyContin.