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New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal
Date:5/26/2009

in 50-mg, 75-mg and 100-mg doses. The FDA-approved trade name for tapentadol is NUCYNTA(TM) (pronounced 'new-sinn-tah'), and the U.S. Drug Enforcement Agency has placed tapentadol into Schedule II of the Controlled Substances Act.

Tapentadol binds to mu-opioid receptors and inhibits norepinephrine re-uptake. Although the exact mechanism of action is not known, these two mechanisms, which affect established pain pathways, are thought to be responsible for pain relief with tapentadol. It is also being developed in an extended release formulation for chronic pain.

Study Design

This Phase 3, double-blind, randomized, active- and placebo-controlled, parallel group, multi-center trial of 901 patients with moderate-to-severe pain following bunionectomy studied the safety and efficacy of tapentadol IR for postoperative analgesia. Patients were randomly assigned in a 4:4:4:1 ratio to receive tapentadol IR 50-mg, tapentadol IR 75-mg, oxycodone HCl IR 10-mg, or placebo every four to six hours over a 72-hour period following surgery. The primary efficacy endpoint was the sum of pain intensity difference (SPID) over the first 48 hours of treatment. The secondary endpoints included SPID over the first 12, 24, and 72 hours of treatment, responder rates at 48 hours based on the reduction of pain intensity compared with baseline, and patient overall status using a 7-point patient global impression of change numerical rating scale. The current study differs from the previously completed Phase 3 bunionectomy study in allowing two doses of acetaminophen 1 g in the first 12 hours of the double-blind treatment period. The allowed use of acetaminophen was intended to improve completion rates in the current study.

IMPORTANT SAFETY INFORMATION

Like other drugs with mu-opioid activity, NUCYNTA(TM) is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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