FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe ...(on. We welcome new proven o...),Health

"We welcome new proven options that can help people with pain," said Mark Rasmussen, President/CEO, The National Pain Foundation, Denver, CO.

PriCara(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market tapentadolin the United States. J&JPRD and Ortho-McNeil-Janssen Pharmaceuticals, Inc. are wholly owned subsidiaries of Johnson & Johnson.

Approval Based on Results of Phase 3 Studies

Multiple Phase 3 studies presented at the 27th Annual Scientific Meeting of the American Pain Society in May showed tapentadol offers patients significant relief of their pain when compared to placebo, and that the medicine was generally well tolerated in these studies.

The studies were conducted in different patient groups, including those who had a bunionectomy, a standard foot surgery associated with predictable levels of moderate to severe pain, and in those with pain from end-stage joint disease.

(http://www.jnj.com/connect/news/all/20080509_160002; http://www.jnj.com/connect/news/all/20080509_160000)

At the same meeting, a Phase 3 safety study of tapentadol immediate-release tablets was presented. This study evaluated tapentadol in patients with low back pain or pain from osteoarthritis of the hip or knee. It demonstrated that tapentadol offers pain relief and is generally well tolerated. (http://www.jnj.com/connect/news/all/20080509_160001)

Two Mechanisms of Action

Mu-opioid agonists are drugs that bind to and activate mu-opioid receptors in the central nervous system. These drugs modify sensory and affective aspects of
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