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J&J Ionsys fentanyl pump for post-surgical pain to launch in 2007

This article was originally published in The Gray Sheet

Executive Summary

Johnson & Johnson subsidiary Alza will launch in 2007 its Ionsys needle-free, patient-activated iontophoresis transdermal fentanyl drug delivery system for post-operative pain, the firm says. FDA approved the system May 22 for short-term management of post-operative pain in adults requiring opioid analgesia during hospitalization. Ionsys' E-Trans delivery technology uses low-intensity electrical current to move a 40 mcg dose of fentanyl from a reservoir into the skin over a 10-minute period. Alza also markets the controlled-release fentanyl patch Duragesic. The road to approval for Ionsys has been relatively long. A September 2003 NDA filing was deemed "approvable" in July 2004. The company resubmitted the application in November 2005...

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