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New Data From Phase 3 Study Suggests Tapentadol Immediate Release Effective for Acute Pain From Common Foot Surgery
Date:5/9/2008

a(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market tapentadol in the United States. The NDA filing is part of the ongoing commitment of J&JPRD and PriCara(TM) to bring new and innovative products to patients and physicians for the treatment and management of pain.

Study Design

This Phase 3, double-blind, randomized, multi-center trial examined the efficacy, safety and tolerability of multiple doses of tapentadol IR in 603 post-surgical bunionectomy patients. Participants were randomly assigned (1:1:1:1:1) to receive tapentadol IR 50, 75, or 100 mg, oxycodone 15 mg, or placebo and the primary efficacy endpoint was the sum of their pain intensity differences at 48 hours. Secondary endpoints included sum of pain intensity differences at 12, 24, and 72 hours.

J&JPRD and Grunenthal GmbH supported this study.

J&JPRD and Ortho-McNeil-Janssen Pharmaceuticals, Inc. are wholly owned subsidiaries of Johnson & Johnson.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD) is a wholly owned subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide. More information can be found at http://www.jnjpharmarnd.com/.

PriCara(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

PriCara(TM), a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a major health care company in the United States dedicated to the needs of primary care providers who serve a vital role on the frontline of medicine. For more information about the co
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SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.
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