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King drug gets priority review in US
14 Aug 2008
Regulatory Affairs
King Pharmaceuticals and Pain Therapeutics have said that their new drug application for Remoxy has been granted priority review by the US Food and Drug Administration.
Remoxy is a controlled-release oxycodone for moderate to severe chronic pain and King states that its liquid formulation encased in a hard gelatin capsule is specially-designed to protect against drug misuse and abuse.
The new drug application was submitted on June 10th and the FDA aims for a decision on medicines with priority review status to be made within six months.
King argues that abuse of controlled-release oxycodone medications is a serious health concern and can lead to addiction and even death.
It adds: "The development of abuse-resistant opioid medications remains a major, but elusive, public health goal."
The company last month announced it had seen total revenues of $397 million (£212 million) during the second quarter of the year.
