FDA Approves New Opioid-Based Pain Medicine

Sat 25 September, 2004 01:15 WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Friday approved a new Purdue Pharma L.P. opioid-based drug that aims to provide "around-the-clock" relief to patients with moderate to severe pain.

Privately-held Purdue also makes OxyContin, another controlled substance that has become known for its abuse potential.

But the Stamford, Conn.-based company has developed a plan to help minimize the risk for abuse of its latest drug, the FDA said in a statement.

The new drug, called Palladone contains a controlled substance called hydromorphone and has "the potential for abuse," the agency said. It will be regulated by the Drug Enforcement Administration, according to the statement.

FDA officials said Palladone should only be used in patients, who are already taking opioid medicines, and who need to take at least 12 milligrams of the oral hydromorphone or its equivalent each day. The extended-release capsules are available in 12, 16, 24 and 32 milligram doses.

"Palladone offers a therapeutic choice for opioid-tolerant patients who might otherwise be candidates for other opioids and who do not achieve satisfactory therapeutic results with these other products," the agency said.

Purdue officials could not immediately be reached for comment.

The company reaped $1.9 billion in U.S. sales last year from OxyContin, which has become known as a popular street drug by people who crush the pill to snort it or inject it for a quick high.

To help curb the possibility of abuse with Palladone, the company said it would provide "clear and appropriate labeling," educate healthcare professionals and "offer appropriate training to sales representatives," according to the FDA's statement.

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