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Results of Phase 3 Study Show Tapentadol IR Relieves Acute Pain and Offers Favorable Gastrointestinal Tolerability Profile
Date:5/9/2008

TAMPA, Fla., May 9 /PRNewswire-USNewswire/ -- Osteoarthritis is a painful and potentially debilitating condition that affects almost 50 million people in the United States. It is caused by deterioration of cartilage in bone joints. The novel investigational pain medication tapentadol, a centrally acting oral analgesic, provided significant relief for patients with joint-disease pain, compared to those treated with placebo, and with fewer gastrointestinal side effects than those treated with an older, prescription pain reliever, researchers announced today.

Results from a Phase 3 clinical study of tapentadol immediate release (IR) tablets showed that patients treated with a 50 mg or 75 mg dose of tapentadol experienced significant relief in end-stage joint disease pain compared to placebo (P<0.001) when assessed over five days of treatment. In addition, patients treated with tapentadol experienced significantly better digestive tract tolerability compared to patients treated with 10 mg of oxycodone IR. Digestive tract tolerability is one of the leading causes of treatment discontinuation for patients who take prescription pain medications.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) presented these new data in a poster session at the 27th Annual Scientific Meeting of the American Pain Society (APS) in Tampa, Florida.

Tapentadol 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.

Mu-opioid agonists are drugs that bind to and activate mu-opioid receptors in the central nervous system. These drugs modify sensory and affective (mood) aspects of pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increases the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells; these compounds have analgesic properties.

The 50 mg and 75 mg tapentadol IR treatment groups showed similar efficacy to the group treated with 10 mg of oxycodone IR. However, compared to oxycodone IR, both doses of tapentadol studied showed a significant reduction in the incidence of gastrointestinal side effects such as nausea, vomiting and constipation. Twenty-six percent of patients treated with 10 mg of oxycodone IR experienced constipation while only four or seven percent of the tapentadol IR groups -- treated with 50 mg and 75 mg respectively -- experienced constipation. In addition, 18 percent of the tapentadol IR 50 mg and 21 percent of the tapentadol IR 75 mg groups reported nausea, which is lower than the oxycodone IR group: 41 percent. There also were fewer reports of vomiting with both doses of tapentadol IR: 7 or 14 percent respectively versus 34 percent with oxycodone IR. The most common adverse events in both treatment groups included nausea, dizziness and vomiting.

"We are encouraged by these study findings, which show that tapentadol IR may offer healthcare professionals a new acute pain treatment option with fewer of the troubling abdominal side effects in the digestive tract," said lead study author Craig T. Hartrick, M.D., Director, Anesthesiology Research, William Beaumont Hospital, Royal Oak, MI. "We believe tapentadol IR has the potential to benefit patients with moderate to severe acute pain."

According to the American Pain Foundation, more than 25 million Americans experience acute pain each year as a result of injuries or surgeries, and a recent study estimated that 42 percent of U.S. hospital emergency department visits were due to pain-related problems. End-stage joint disease is a painful condition often caused when protective joint ligaments are worn away and over time, bones are left to rub against one another.

The use of tapentadol IR for the treatment of moderate to severe 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

In a Phase 3, double-blind, randomized, placebo-controlled, multi-center trial 659 candidates for primary joint replacement surgery for end-stage joint disease were randomly assigned to receive an oral dose of placebo, tapentadol IR 50 or 75 mg, or oxycodone IR 10 mg every four to six hours. The sum of pain intensity over five days was analyzed as well as at the two- and 10-day time points. Treatment emergent adverse events occurred in 52 percent of patients treated with tapentadol IR 50 mg, 71 percent treated with tapentadol 75 mg and 84 percent of those treated with oxycodone 10 mg.

Craig T. Hartrick, M.D., is a consultant to J&JPRD. 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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