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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

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