MANSFIELD – The U.S. Food and Drug Administration has extended to Feb. 22 its deadline for deciding whether to approve the drug Exalgo, a painkiller licensed last summer by Covidien Plc.
Exalgo – the brand name of hydromorphone HCl – is an extended-release tablet “for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time,” according to Covidien, which said it has not included the drug in its fiscal 2010 sales forecast.
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Covidien paid $10 million cash in June to get the U.S. commercialization rights to Exalgo from Neuromed Pharmaceuticals Ltd. The agreement says Covidien will pay up to $73 million to Neurmoed and Alza Corp., the drug’s original developer, if Exalgo is successfully approved and sold.
The FDA extended its deadline by three months after Covidien and Neuromed recently provided additional information on Exalgo at the agency’s request. The companies held a meeting with regulators about the drug on Nov. 13.
“We are committed to providing patients with advanced pain medications and are optimistic that Exalgo will be approved,” said Timothy R. Wright, the president of Covidien’s pharmaceuticals division. “We will continue working with Neuromed and the Agency on securing approval for Exalgo.”
