Actiq Should Get FDA Hearing Soon

Anesta should get a requested meeting on Actiq (fentanyl citrate), itslollipop treatment for chronic and breakthrough pain in cancer patients, with the US Food and Drug Administration before the end of the year, the company's chief executive, William Moeller, told attendees at a BancAmerica Robertson Stephens Medical Conference.

Last month, the FDA sent the company a "not approvable" letter (Marketletter November 24), which Anesta commented was a surprising move since it had been collaborating with the FDA in the Actiq development program for the previous four years. Furthermore, an FDA advisory committee had unanimously voted for approval of the drug to treat breakthrough pain in patients already on opioid analgesia.

The FDA wanted more information on manufacturing and labeling, said company president Tom King, who added that its concern that the lollipop-shaped opioid might be used illicitly or accidentally ingested by children might not be preventable. Mr Moeller told investors that FDA approval is still likely, and pointed to strong efficacy and safety data. The issue is the relative benefit for the intended population, he said. If approved, Actiq will be marketed in the USA by Abbott Laboratories, which has a 13% stake in the company.