Cephalon receives approval for drug to treat cancer pain

Cephalon Inc. won U.S. regulatory approval to market a pain medication that's based on the main ingredient in the company's Actiq drug, which is made in Salt Lake City and faces generic competition later this year.

The Food and Drug Administration approved Fentora for intense pain that occurs in cancer patients even though they're on other pain medication, Cephalon, based in Frazer, Pa., said Monday in a statement. Studies showed the rapid-release tablet, which contains fentanyl, reduced pain in as little as 15 minutes for cancer patients already taking opiates.

Fentora is the first tablet designed to dissolve in the mouth and allow the drug to be absorbed directly across the lining of the upper cheek to treat so-called breakthrough pain, Cephalon said. Fentora may help the company recover sales after Actiq, its No. 2 drug, loses patent protection later this year.

Cephalon issued the announcement after U.S. markets closed. The shares climbed 37 cents to $59.27 at 7:02 p.m. New York time in late trading, after rising $1.46, or 2.5 percent, to close at $58.90 in Nasdaq Stock Market composite trading. The stock had gained 26 percent in the 12 months before today.

The company's best-selling sleep-disorder drug, Provigil, is protected from competition for five more years under agreements signed with generic drugmakers. Cephalon said in July that the U.S. Federal Trade Commission asked for more information about the patent settlements.

About 800,000 cancer patients will have breakthrough pain, the company said, citing data from the American Cancer Society.

Cephalon has said it will distribute Fentora cautiously because the drug is a narcotic and easy to use.