Purdue pulls Palladone over alcohol risk
Purdue Pharma withdrew its Palladone painkiller from the market at the request of the Food and Drug Administration, which cited an "unacceptably high level of patient risk" over adverse interaction with alcohol.
The withdrawal dealt the Stamford, Conn.-based, privately-owned firm another harsh blow just days after it announced it was slashing its workforce by 825, or 38 percent, following a federal appeals court ruling that invalidated patents for its biggest-selling drug, OxyContin, clearing the way for generic competition.
Pallone won approval only last October for the management of persistent moderate to severe pain in patients requiring continuous pain relief for an extended period of time. The drug, launched in February, was prescribed to 11,500 patients, said Purdue. By contrast, OxyContin is prescribed to millions and makes up three-quarters of the company's sales.
In a statement, the company said it was weighing the possibility of seeking approval to market Palladone in certain institutional settings, such as hospitals and in-patient hospices, per FDA permission.
"Palladone was launched by Purdue with clear and strong warnings about alcohol interaction," the statement said. "Purdue believed these warnings, and modifications to our Risk Management Program, appropriately addressed this risk. Yesterday, the FDA advised Purdue that it has concluded that the risk of alcohol interaction cannot be adequately managed with warnings."