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New Study Suggests Tapentadol IR for Acute Pain Is Associated With Improved Gastrointestinal Tolerability Compared to Oxycodone IR
Date:5/9/2008

TAMPA, Fla., May 9 /PRNewswire-USNewswire/ -- Many strong acting pain medications have bothersome side effects. These can include nausea and vomiting with short-term use, and constipation with longer, chronic use. Such symptoms can lead patients to discontinue treatment, adding additional complications to pain management for physicians. The novel investigational medication tapentadol, a centrally acting oral analgesic, provided pain relief for patients with fewer gastrointestinal side effects than those treated with an older, prescription pain reliever, researchers announced today.

Data from a new Phase 3 clinical study of tapentadol immediate release (IR) tablets demonstrated that tapentadol has a significantly improved gastrointestinal tolerability compared with oxycodone IR for treatment of acute pain and was well-tolerated when taken for up to 90 days.

These new data are being presented today in a poster session at the 27th Annual Scientific Meeting of the American Pain Society (APS) in Tampa, Florida. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), Raritan, NJ, supported this study and its presentation.

In this study, patients with low back pain or pain from osteoarthritis of the knee or hip were treated with a flexible dose of 50 mg or 100 mg of tapentadol IR every four to six hours, up to a maximum of 600 mg/day, or a flexible dose of 10 mg or 15 mg of oxycodone IR every four to six hours, up to a maximum of 90 mg/day; patients were treated for up to 90 days. While both tapentadol IR and oxycodone IR offered pain relief, the tapentadol IR treatment group experienced a statistically significantly lower incidence of nausea, vomiting, constipation and composite nausea/vomiting (P<0.001) for all treatment comparisons. Overall, the percentage of patients with treatment emergent adverse events in the tapentadol IR group, at 76 percent, was lower than the percentage in the oxycodone IR group at 83 percent. The most common treatment emergent adverse events for both groups were nausea, vomiting, dizziness, constipation, headache, and somnolence (drowsiness). While the incidence of nausea, vomiting, constipation and the composite nausea and vomiting were significantly lower in the tapentadol IR treated groups compared to the oxycodone IR groups, the incidences of dizziness and somnolence (drowsiness) were not significantly different between the treatment groups.

"Gastrointestinal side effects, such as constipation, from centrally acting opioid pain medicines can be a treatment complication for pain patients and their healthcare professionals," said David Upmalis, M.D., Senior Director, CNS/Pain, J&JPRD. "Our study shows that tapentadol IR may offer improved gastrointestinal tolerability compared to other strong pain medications. Such a difference could improve patient treatment, and provide healthcare professionals an additional therapeutic option to treat acute pain."

Tapentadol is a novel investigational, centrally acting oral analgesic. It has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition in a single molecule. It is being developed in immediate-release formulation for acute pain and extended-release formulation for chronic pain.

The use of tapentadol IR for the treatment of moderate to severe acute pain is under review by the United States Food and Drug Administration. The New Drug Application (NDA) was filed on January 23, 2008. Upon FDA approval, PriCara(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, active-control, parallel group, multi-center trial of 878 patients with low back pain or pain from osteoarthritis of the knee or hip studied the tolerability of long-term exposure (90-days) to tapentadol IR. Patients were randomly assigned in a 4:1 ratio to a flexible dose of either tapentadol IR (50 or 100 mg/dose; maximum 600 mg/day) or oxycodone IR (10 or 15 mg/dose; maximum 90 mg/day) every four to six 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 company, please visit http://www.PriCara.com.

Grunenthal

Grunenthal, a privately owned pharmaceutical company based in Aachen, Germany, discovered and started development of tapentadol. Grunenthal and J&JPRD have shared development responsibilities for tapentadol for acute and chronic pain conditions since the companies signed a licensing agreement for tapentadol in 2003.

Grunenthal licensed marketing rights to tapentadol to Ortho-McNeil-Janssen Pharmaceuticals, Inc. for the United States, Canada and Japan. Grunenthal maintains marketing rights in Europe and other parts of the world. A trade name for the product has not yet been determined.

[This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Company's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.]

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