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From: CNN Acura Pharmaceuticals Inc. (ACUR), King Pharmaceuticals Inc. (KG) and other companies developing pain drugs that don't contain acetaminophen could get a boost from Tuesday's recommendation by a U.S. panel of experts to limit use of acetaminophen in order to reduce liver injuries. Acura shares recently rose 46 cents, or 7.69%, to $6.44, while King shares were up 2 cents at $9.65. A Food and Drug Administration advisory committee recommended banning widely used prescription pain drugs containing acetaminophen, such as Abbott Laboratories' (ABT) Vicodin and Endo Pharmaceuticals Holdings Inc.'s (ENDP) Percocet, as well as reducing dosing levels of acetaminophen in over-the-counter products such as Johnson & Johnson's (JNJ) Tylenol. The experts were concerned that current dose levels can cause liver damage if used in certain ways.
Some analysts doubt the FDA will actually remove the prescription drugs from the market as recommended, instead opting to lower the dose of acetaminophen in them. Still, the recommendations could prompt a shift away from acetaminophen- containing prescription painkillers and toward greater use of alternatives.  A potential future alternative is Acurox, a drug co-developed by King and Acura and currently under review by the FDA. Acurox is a single-dose tablet containing the opiate oxycodone - which is sold separately as OxyContin and other brands - plus the drug niacin. It's designed to deter abuse by causing unpleasant effects if it's crushed or taken excessively. "The wave of the future is to move toward these abuse-deterrent systems," said Natixis Bleichroeder analyst Corey Davis. "The news here is the FDA is now really hell-bent on protecting against [acetaminophen]-induced liver toxicities. Acurox has abuse deterrence and it doesn't have acetaminophen." Still, FDA approval of Acurox may not be so smooth. A decision from the FDA was originally expected by Tuesday, but no announcement has been made. Spokespeople for King and Acura couldn't immediately be reached. Two weeks ago, the FDA sent Acura a letter with "preliminary comments" about the Acurox application, which led Acura and King to conclude the FDA was unlikely to approve the drug by the expected action date of June 30. Davis said he'd be surprised if FDA approved the drug in coming days or weeks, but it might by year's end. The FDA has taken a closer look at certain painkillers this year. In February the agency said opioid products would be required to have "risk evaluation and mitigation strategy" plans to ensure that the drugs' benefits continue to outweigh the risks. Davis of Natixis Bleichroeder believes these plans will shift use away from extended-release opioids and toward alternatives. Endo shares recently fell 27 cents, or 1.5%, to $17.65, reflecting concerns about Percocet. J&J shares were off 30 cents at $56.50, while Abbott was off 35 cents at $46.69. |
