* Drug meant to deter abuse of long-acting morphine
* Approved to treat moderate to severe pain
* Shares rise 2 percent in after-market trade (Adds analyst, FDA comments, updates shares)
By Ransdell Pierson
NEW YORK, Aug 13 (Reuters) - King Pharmaceuticals Inc KG.N on Thursday said U.S. regulators had approved Embeda, its pain medicine meant to help thwart abuse by those who crush or chew long-acting opioid drugs to get a euphoric but dangerous high, lifting company shares 2 percent.
The morphine-based drug was approved to treat moderate to severe pain when a continuous opioid painkiller is needed over an extended period. It will be available in either once- or twice-daily dosages.
Embeda contains extended-release morphine pellets wrapped around naltrexone hydrochloride, a drug that counteracts the effects of morphine, which is an opioid.
“If taken as directed, the morphine relieves pain while the sequestered naltrexone hydrochloride passes through the body with no intended clinical effect,” King said in a release.
But if crushed or chewed, the naltrexone is released and absorbed with the morphine, King said, to some extent reversing morphine’s effects.
“The clinical significance of the degree of this reduction has not been established,” King cautioned in a release, and the company also noted that there is no evidence that the naltrexone in Embeda reduces the risk of abuse.
Although Embeda is the first U.S.-approved long acting opioid designed to counter such abuse, King cautioned it still carries risk.
“Because Embeda is an extended-release product, it should not be chewed, crushed, or dissolved due to the risk of rapid release and absorption of a potentially fatal dose of morphine,” King said.
The FDA, in a statement, said intravenous injection of crushed Embeda can cause serious injury or death due to a morphine overdose or blood blots.
Robert Hazlett, an analyst with BMO Capital Markets, predicted Embeda would garner peak annual sales of $400 million even though questions remained as to whether the drug was thoroughly tested.
Hazlett boosted his 2010 earnings forecast for King by 2 cents per share, to $1.22, saying Embeda will likely wrest sales away from the company’s already marketed Avinza brand of morphine. The company has total annual sales of about $1.8 billion.
King acquired Embeda as part of its $1.6 billion deal for drugmaker Alpharma.
King is counting on Embeda and a number of its other drugs now in development to help it become a leader in the field of abuse-resistant painkillers, which it hopes will offset slower sales of drugs such as its Altace blood pressure medicine.
The U.S. Food and Drug Administration in December declined to approve Remoxy, King’s long-acting version of the potent oxycodone painkiller being developed in partnership with Pain Therapeutics Inc. (PTIE.O)
The companies last month said they may not resubmit their marketing application for Remoxy until the middle of next year.
Shares of King rose to $10.79 in after-hours trading, from their closing price of $10.59 Thursday on the New York Stock Exchange.