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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. Nor
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SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.
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