Patient-Controlled Transdermal System for Pain Mgmt.

[Dave ARNP]

Study Shows Positive Results for Novel, Patient-Controlled Transdermal System for Acute Postoperative Pain Control

RARITAN, NJ -- February 25, 2004 -- A study evaluating a novel, patient-controlled, needle-free system for delivering pain medication to post-operative patients through the skin found that those who were on the patient-controlled transdermal system (PCTS) withdrew from pain treatment less often because of inadequate pain control versus placebo.

The study, which was published in the February issue of the journal Anesthesia & Analgesia found that 25.4% of patients who received E-TRANS® Fentanyl HCI Patient-Controlled Transdermal System (PCTS), an investigational needle-free system being studied for post-surgical pain, withdrew from treatment because of inadequate pain control compared with 40.4% in the placebo group [p

E-TRANS Fentanyl HCI PCTS is a self-contained, pre-programmed system approximately the size of a credit card. The system was designed to provide patients with personal control over their pain management requirements without the lines, needles, poles and pumps required by currently available intravenous PCA systems. Designed to adhere to a patient's upper arm or chest, E-TRANS Fentanyl HCl PCTS uses low-intensity electrical current -- which cannot be felt by the patient -- to deliver medication directly into the skin.

Patients control E-TRANS Fentanyl HCl PCTS at the push of a button, and the system immediately delivers a small dose of the short-acting analgesic fentanyl, a prescription pain medication that has been used safely and effectively for more than 30 years.

If approved by the U.S. Food and Drug Administration (FDA), E-TRANS Fentanyl HCl PCTS will be utilized in the management of acute pain requiring opioid analgesia.

"It is important that we explore new approaches and technologies to improve patients' comfort in the post-surgical setting," said study investigator Jacques E. Chelly, MD, PhD, Vice Chair of Clinical Research and Director of Orthopedic Anesthesia and Acute Pain Services, Department of Anesthesiology, 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 common adverse events observed were related to study medication, including nausea, general itching (pruritus), vomiting and headache. Local skin reactions where the system was applied were reported by 5.2% of E-TRANS Fentanyl HCI patients versus 10% in the placebo group. Adverse events that were considered by the investigator to be related to the study medication were experienced by 46% of patients who received E-TRANS Fentanyl HCI PCTS and by 33% of those who received placebo. Only one E-TRANS Fentanyl HCI PCTS patient had a serious adverse event that was considered to be related to treatment (moderate nausea and vomiting, and severe urinary retention). Thirteen patients discontinued study treatment because of an adverse event; 8 (5.6%) who received E-TRANS Fentanyl HCI PCTS and 5 (10.6%) who received placebo.

ALZA Corporation, headquartered in Mountain View, California, is leading the next generation of drug delivery and drug targeting, with the world's broadest array of technology platforms.

Ortho-McNeil is based in Raritan, NJ. The company markets pharmaceutical products in several therapeutic categories including infectious diseases, women's health, central nervous system and urology.

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