Cephalon gets approvable letter for Fentora to manage breakthrough pain

By Elaine Rigoli

Tampa, Fla., June 29 - Cephalon, Inc. has received an approvable letter from the Food and Drug Administration for Fentora (fentanyl buccal tablet), a drug to treat breakthrough pain.

The company submitted a New Drug Application in August 2005, seeking to market Fentora for the treatment of breakthrough pain in opioid-tolerant patients with cancer.

Cephalon said it intends to submit a response to the FDA by the end of July and expects the FDA to classify this response as a class 1 resubmission under which the FDA will seek to complete its review within 60 days of the resubmission.

The FDA has indicated that no additional safety or efficacy data are required and that the labeling has been essentially finalized.

On a separate matter, Barr Laboratories, Inc. has invoked its option under the license and supply agreement with the company to have Cephalon manufacture for it a generic version of Actiq (oral transmucosal fentanyl citrate). Cephalon expects to deliver bulk units to Barr, and Barr will be responsible for all packaging and labeling of the product.

Cephalon is an international biopharmaceutical company based in Frazer, Pa.

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