Anesta's Actiq "Not Approvable"

Anesta Corp has received a "not approvable" letter from the US Food andDrug Administration for Actiq (fentanyl citrate), its lollipop treatment for chronic and breakthough pain in cancer patients. Shares were down $6, or 29%, on the day of the announcement.

William Moeller, chief executive officer, said in a statement that the company was surprised, and added that the letter was puzzling in light of its collaboration with the FDA in the Actiq clinical program during the past four years. Earlier this year, an FDA advisory committee voted 19-0 to recommend approval of the drug to treat breakthrough pain in patients already on opioid analgesia (Marketletter October 6).

The FDA decision was probably based on balancing the drug's benefits to its intended population with the risks it may pose to unintended users, said Mr Moeller, adding that the agency simply needed more time to evaluate the situation.