J&J wins US OK for needle-free painkiller system

Last Updated: 2006-05-23 13:00:26 -0400 (Reuters Health)

NEW YORK (Reuters) - Johnson & Johnson on Tuesday said U.S. regulators approved its Ionsys device by which patients who have had surgery can deliver controlled amounts of painkiller through the skin by the touch of a button while in the hospital.

The J&J device uses the same opioid painkiller, a compound called fentanyl, that is used in the company's Duragesic skin patch that recently lost patent protection and is now facing generic competition.

But unlike Duragesic, the new Ionsys system uses a weak electric current to deliver pre-programmed amounts of fentanyl across an adhesive strip on the skin and into the bloodstream.

JP Morgan analyst Michael Weinstein forecast sales of $40 million in the second half of this year for the needle-free pain drug delivery system, rising to $275 million in 2009.

J&J's Alza unit received conditional approval for Ionsys in July 2004, but the U.S. Food and Drug Adminstration said it would need additional data before granting outright approval. The company submitted the requested data last November.

"This is the only needle-free, patient-administered analgesic system," company spokesman Paul Minehart said.

Minehart said the device has built-in safeguards to ensure patients do not overmedicate themselves.