Johnson & Johnson's extended-release pain drug Nucynta approved in US

Johnson & Johnson's Janssen Pharmaceuticals unit announced Friday that the FDA authorised an extended-release version of Nucynta (tapentadol) for the management of moderate to severe chronic pain in adults when an opioid analgesic is needed for a prolonged period.

Last year, the regulator issued a complete response letter for the twice-daily drug and requested further information about the product’s tamper-resistant formulation. Johnson & Johnson submitted its response to the FDA in February this year.

Johnson & Johnson noted that the product, which is classified as a schedule II controlled substance, has been approved with a risk evaluation and mitigation strategy to inform doctors about the potential for abuse, misuse, overdose and addiction from exposure to Nucynta.

An immediate-release version of the drug was approved in the US in November 2008. Analysts predict that sales of Nucynta, which is marketed by Grunenthal in certain European countries as Palexia, could reach $262 million next year.

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