Cephalon Drug Partly Cleared

The Food and Drug Administration has delayed approval of an experimental cancer-pain drug from Cephalon (CEPH), but the company says it expects final clearance this year, perhaps within three months.

"We are pleased with FDA's response and are working closely with the agency to secure final approval of this important new medication," said Dr. Paul Blake, an executive vice president, in a prepared statement issued Thursday.

The drug, to be sold under the brand name Fentora, won't need any additional safety or efficacy data, the company said. That may explain why Cephalon's shares gained $4.84, or 8.9%, to $59.10 in after-hours trading Thursday.

The FDA sent Cephalon an "approvable letter," meaning the drug will be acceptable if and when the company meets certain conditions. Cephalon, which didn't describe the conditions, said it will respond to the agency by the end of July. Then, regulators will take 60 days to review the application.

Cephalon added that the FDA indicated that the labeling has been essentially completed. In May, Frank Baldino Jr., Cephalon's chairman and CEO, predicted the agency would grant an approvable letter for the drug. Cephalon also is waiting to hear from the FDA on a treatment for attention deficit hyperactivity disorder and another for sleep problems.

Fentora treats "breakthrough pain," or an intense, fast-occurring pain that lasts for a short time. Fentora uses a technology that enables a patient to place the pain tablet between their upper cheek and gum, allowing quick delivery of the medication. One clinical study showed that the drug could provide relief in as little as 15 minutes, Cephalon said.

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