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

mmon 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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24-Feb-2004


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