Study shows positive results for novel, patient-controlled transdermal system (PCTS)...

iology, Pittsburgh School of Medicine. Annually, an estimated 20 million people in the U.S. require injectable opioids for the treatment of acute post-surgical pain.

A new-drug application was filed with the U.S. Food and Drug Administration in September 2003 by ALZA Corporation for the use of E-TRANS Fentanyl HCI PCTS for acute pain management requiring opioid analgesia in a medically supervised setting; a filing in the European Union is expected in 2004. ALZA Corporation developed the E-TRANS (electrotransport) system technology. If approved by the FDA, E-TRANS Fentanyl HCI PCTS will be marketed by Ortho-McNeil Pharmaceutical, Inc. in the United States and Janssen-Cilag in Europe. ALZA, Ortho-McNeil and Janssen-Cilag are subsidiaries of Johnson & Johnson.

This randomized, double-blind, placebo-controlled study included 154 patients treated with E-TRANS Fentanyl HCI PCTS and 51 patients treated with placebo. Of these, 142 patients randomized to E-TRANS Fentanyl HCI PCTS and 47 to placebo who stayed in the study 3 hours or longer were valuable for efficacy analyses. All patients were evaluated for safety and were made comfortable with supplemental intravenous opioids during the first three hours of the trial before using the system. More than half of all patients had undergone lower abdominal surgical procedure. Other patients in the study had undergone orthopedic or thoracic surgery. Patient demographics (age, height, weight and body mass index) were similar between the two groups at baseline.

The primary efficacy endpoint was the proportion of patients who dropped out due to inadequate analgesia. Additionally, the last level of pain recorded by patients in the study was lower in the E-TRANS Fentanyl HCI PCTS group than in the placebo group. A higher proportion of patients and investigators also reported greater pain control with E-TRANS Fentanyl HCI PCTS than with placebo based on global assessments of pain intensity.

The most co


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