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Phase 3 Open-Label Study Comparing Tapentadol Extended Release Tablets to Oxycodone Controlled Release Tablets Published by Pain Practice
Date:7/19/2010

) and headache (tapentadol ER, 13.3; oxycodone CR, 7.6). In the tapentadol ER and oxycodone CR groups, respectively, TEAEs led to discontinuation in 22.1 percent and 36.8 percent of patients.

Chronic pain, affecting an estimated 100 million Americans, continues to be a significant medical challenge in the United States. Osteoarthritis pain and low back pain are particularly prevalent – osteoarthritis pain affects 27 million Americans, and chronic low back pain is the most common cause of disability in developed countries.

Although currently available long-acting opioid analgesics have been shown to provide relief for moderate to severe chronic pain, many are associated with high incidences of side effects, which can cause patients to discontinue their treatment. Research also shows that physicians are uncomfortable prescribing opioids due to these opioid-related side effects.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) and Grunenthal GmbH, conducted this study, which J&JPRD has included as part of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol ER tablets for the management of moderate to severe chronic pain in patients 18 years of age or older. The FDA currently is reviewing this application and, if approved, PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market tapentadol ER in the United States.

The full article in Pain Practice can be accessed online at http://www3.interscience.wil
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