King Pins Job Hopes On Three New Drugs

King Pharmaceuticals is working on three drugs its executives hope will treat pain, deter prescription drug abuse and bring new jobs to the region.

An application for the latest, Acurox, was delivered to the U.S. Food and Drug Administration on Friday.

Linda Wase, King’s executive vice president for medical affairs, said Acurox and the two other drugs in the federal approval process, Embeda and Remoxy, each contain a standard pain medication but have a special twist designed to prevent “people who are trying to get high” from abusing them.

Acurox is an immediate-release, oxycodone pain killer that King is developing in part with Acura Pharmaceuticals out of Palatine, Ill.

What makes the drug special, Wase said, is that “when the formulation gets exposed to a liquid it gets gooey.” That by-product, she said, is too thick to go through a syringe and be injected into the arm of a would-be prescription drug abuser.

Wase said Acurox tablets also contain niacin, a chemical that causes such unpleasant side-effects as headaches and sweating if taken in large doses. But those side effects, King spokesman James Green said, kick in only if a person takes many more pills than the recommended dosage, or what is prescribed by a doctor.

Green said the company asked the FDA on Friday for an expedited review of Acurox.

Expedited reviews take about 60 days to complete, while the normal drug approval process can take anywhere from nine months to a year. Before that process even starts, however, new drugs must undergo a series of clinical trials. And, their manufacturers must complete another approval process, known as the investigational new drug application process, before those clinical trials can take place. Both of those processes for Acurox are complete.

According to the FDA Web site, the agency’s Center for Drug Evaluation and Research approved 16 new prescription drugs in December.

The center was due to give another King pain medication, Embeda, an up or down vote Tuesday, but on Wednesday, Green announced that the vote was delayed and the review is continuing.

Bridgewater, N.J., pharmaceutical company Alpharma is responsible for developing Embeda, an extended-release, morphine-based pain killer that features a special naltrexone core to prevent abuse.

King Pharmaceuticals bought Alpharma on Tuesday for $1.6 billion after about four months of public and private negotiations.

Green said Alpharma’s drugs, especially Embeda, would fit nicely with King’s current offerings.

Wase said Embeda’s naltrexone core can prevent prescription drug abuse because it negates the morphine’s effects if the pills are crushed. People crush drugs to be snorted or injected, she said, so they can get to the medication’s effects faster than if they took the pills orally as prescribed.

Green said Embeda’s review likely will “extend into early 2009.”

King’s third abuse-preventing painkiller, Remoxy, a gel caplet containing oxycodone in a highly viscous liquid form to prevent abuse, finished its drug approval process Dec. 11. But the drug did not get the initial results King executives had sought.

The Food and Drug Administration asked King and Remoxy’s co-developer, Pain Therapeutics Inc., to provide more non-clinical information before it gave the drug a final yes or no.

Green said this type of action is a pretty common result in the overall drug approval process, and while it does not mean the drug has been rejected, it did delay King’s plans to roll out the pain medication this quarter.

He said King’s Bristol facility would be used as a secondary manufacturing site for Remoxy if and when the drug is approved. The company also plans to make Acurox at its Bristol plant, he said, which might bring more jobs to the region.

“There could be some increased head count over time [at the Bristol facility] as these drugs come in,” Green said, adding the King already makes 11 drugs at its Bristol plant.

Headquartered in Bristol, Tenn., King employs more than 2,000 people at its plants in Bristol and five other states. King’s stock price closed Friday at $10.79, up 17 cents from Thursday.

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