GAITHERSBURG, MdAn FDA advisory committee voted unanimously to recommend Anesta Corporations Actiq (oral transmucosal fentanyl(Drug information on 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.
