PHARMACY

King Pharmaceuticals to present study findings at American Pain Society’s Annual Meeting

BY Allison Cerra

SAN DIEGO, Calif. King Pharmaceuticals will present study findings from its expanded pain management portfolio at the American Pain Society’s Annual Meeting, the company announced Thursday.

Leading researchers are presenting safety and efficacy data for Acurox and scientific data confirming validation of innovative measurement standards to evaluate the likeability of such opioid analgesics as Embeda.

The company is developing several novel opioid treatment options, including long-acting opioids Embeda and Remoxy, and a short-acting opioid, Acurox, each of which is uniquely designed to deter misuse and abuse commonly associated with currently approved opioid analgesic products.

Acurox is an investigational patented, orally-administered, immediate-release tablet containing oxycodone HCl as its sole active analgesic ingredient with a proposed indication for the relief of moderate to severe pain. Acurox utilizes Acura’s proprietary Aversion Technology, which is designed to deter misuse and abuse by intentional swallowing of excess quantities of tablets, intravenous injection of dissolved tablets and nasal snorting of crushed tablets. Remoxy, an investigational drug, is a unique, controlled-release oxycodone for moderate-to-severe chronic pain. Remoxy is a high viscosity, liquid formulation in a hard gelatin capsule that is designed to resist common methods of misuse and abuse.

New drug applications for Acurox, Embeda and Remoxy are all currently under review by the Food and Drug Administration.

“The variety and magnitude of data being presented at the American Pain Society Annual Meeting demonstrates the commitment King has made to advancing pain management,” said Dr. Eric Carter, Chief Science Officer of King Pharmaceuticals. “We expect to meet the need for effective opioid therapeutic options that also have the potential to reduce the risk of inappropriate or non-therapeutic use through our novel pain treatment product candidates.”

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Pfizer signs licensing agreement with Wisconsin Alumni Research Foundation

BY Alaric DeArment

MADISON, Wis. The world’s largest drug maker has signed a licensing agreement with a patenting and licensing organization for the Univeristy of Wisconsin-Madison to use human embryonic stem cell patents to develop new drug therapies.

Pfizer said that under its agreement with the Wisconsin Alumni Research Foundation, the license will the company the rights to work with hES cells for drug research and discovery.

“Our license with WARF provides us with information and materials that will allow us to use their cell lines to explore a whole range of therapies,” Pfizer Regenerative Medicine chief scientific officer Ruth McKernan said. “Stem cells can be used to create specialized human tissue. Our scientists will determine how new medicines may be able to improve the way stem cells regenerate damaged tissues.”

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GlaxoSmithKline to sell U.S. Wellbutrin XL rights to Biovail Corp.

BY Alaric DeArment

RESEARCH TRIANGLE PARK, N.C. A drug maker announced Wednesday that it would give up U.S. rights to the extended-release formulation of a popular antidepressant.

GlaxoSmithKline said it would divest full commercial rights to Wellbutrin XL (bupropion hydrochloride) in the United States, selling it to Biovail Corp. for $510 million. Generic competition to Wellbutrin XL began at the end of 2006 for the 300-mg tablets and during the second quarter of 2008 for the 150-mg tablets. The drug had sales of $60 million in first quarter 2009.

“We are actively reshaping our U.S. business and managing the transition occurring in our product portfolio,” GSK president North American pharmaceuticals Deirdre Connelly said. “This transaction is one of a series of actions we are taking to maximize the value of our current assets and to enable us to resource and invest in new products and upcoming launches.”

Under the terms of the agreement, GSK will transfer the regulatory approval application and trademark for Wellbutrin XL to Biovail for use in the United States, though it will retain rights to the drug for other countries.

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