FDA Advisory Panel Recommends Approval of Actiq

GAITHERSBURG, Md—An FDA advisory committee voted unanimously to recommend Anesta Corporation’s Actiq (oral transmucosal fentanyl citrate) for approval for use in cancer patients with breakthrough pain.

The panel acknowledged a possible danger of accidental poisoning to children, since the product (a sweetened lozenge impregnated with fentanyl attached to a handle) resembles a lollipop, but felt that the benefit outweighed the risk.

Anesta designed the product to be unappealing to children and will package it in a foil pouch considered childproof up to age 4. In addition, distribution of the product, if approved, would be limited and strictly controlled.