Johnson & Johnson's Nucynta OKed by US FDA for moderate to severe chronic pain

US health care giant Johnson & Johnson (NYSE: JN) group company Janssen Pharmaceuticals says that the US Food and Drug Administration has approved the marketing of Nucynta ER (tapentadol), an oral analgesic taken twice daily, for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

The drug, which is licensed from German family-owned drugmaker Grunenthal, was approved it an immediate-release form by the FDA in November 2008. Grunenthal has already released a prolonged release version of tapentadol under the Palexia brand name in the UK (The Pharma Letter May 16, 2011.

Although the exact prevalence is unknown, information from the Centers for Disease Control and Prevention and the American Pain Foundation suggests that more than 42 million Americans aged 20 and over suffer from chronic pain. Chronic pain is the most common cause of long-term disability, and almost one-third of all Americans will experience severe chronic pain at some point in their lives. Yet despite the treatments available, additional treatment options still are needed to help patients manage their pain appropriately and effectively, according to research published by the American Pain Society.