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FDA Panel Recommends Approval of Experimental King Pharma/Pain Therapeutics Drug Abuse-Resistant Remoxy

According to an FDA advisory panel, Pain Therapeutics Inc. and King Pharmaceuticals Inc.´s experimental pain pill Remoxy is less susceptible to abuse than Purdue Pharma LP´s OxyContin. Remoxy capsules contain a thick gel and were designed to resist crushing, dissolving into a liquid or other forms of misuse. Further Details.
11-14-2008 |  07:29 hs.
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An experimental painkiller from King Pharmaceuticals Inc and Pain Therapeutics Inc appears to be less susceptible to abuse than PurduePharma LP´s OxyContin, members of a U.S. advisory panel said.

A majority of outside advisers to the Food and Drug Administration spoke favorably of Remoxy's tamper-resistant characteristics at a meeting. The FDA had asked for advice on whether Remoxy was different enough from other narcotic drugs to conclude it would be abused less and how much information about tamper-resistance should be included on prescribing instructions.

U.S regulators will make a final decision on whether to approve Remoxy. The panel's chairman said the members' views were not a formal vote as the agency had not requested one.

Pain Therapeutics and King are among a half-dozen companies racing to introduce the first drugs for chronic pain that can't be crushed, snorted or injected for a quick high. Remoxy capsules contain a thick gel and were designed to resist crushing, dissolving into a liquid or other forms of misuse.

The FDA is scheduled to act on the drugmakers' application for Remoxy by Dec. 10 under a six-month priority review granted to drugs the agency considers significant improvements over available therapies.

Pain Therapeutics, which has no FDA-approved products on the market now, would receive 15 percent royalties from Remoxy sales if it is cleared. King would handle marketing.

Sales may be $300 million to $1.6 billion in 2010 depending on competition from OxyContin and other products, according to Corey Davis, an analyst at Natixis Bleichroeder.

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