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Purdue suspends sales of pain drug Palladone at the request of the FDA

–August 2, 2005

Purdue Pharma L.P. just lost its patent protection on the controversial painkiller OxyContin, and now the company has suspended the sale of one of its other pain medications in response to an FDA request.

The FDA determined the risk of patients potentially drinking alcohol while taking Palladone could not be adequately managed with product warnings. Palladone was launched in February on a limited basis, but the drug was found to have potentially fatal effects when mixed with alcohol.

The agency requested the company voluntarily suspend its marketing of Palladone, which is yet another hit for the drug company. Purdue recently cut jobs in response to the expected impact to the company's revenues when competitors begin selling generic alternatives of OxyContin for as little as one-third the price.

Purdue spokesman James Heins said it is too early to say if the Palladone withdrawal would lead to additional cuts at the company, but so far, the drug had only been prescribed to 11,500 patients. While not a huge drug for Purdue as of yet, Heins said Palladone sales were included in revenue projection for the future, with plans to market it before generic OxyContin became an issue. Purdue said it plans on reformulating Palladone to adequately address the alcohol interaction safety risks so that the drug can be reintroduced to the market.

For more information on Palladone and alcohol interactions, please contact us to confer with an attorney.


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