• 9/28/2006
  • Frazer, PA
  • staff
  • Chron.com

Drug maker Cephalon Inc. has received Food and Drug Administration approval to market its cancer pain treatment Fentora.

The company expects to launch the drug in October. Cephalon said late Monday the drug is the first oral cancer-pain reliever that is absorbed directly into the blood stream via the cheek lining.

Conventional short-acting oral opioids are swallowed and absorbed in the gastrointestinal tract, which can take up to 30 to 45 minutes to take effect.

Fentora is currently indicated for those cancer patients who are already receiving and are tolerant to opioid therapy for breakthrough pain, a common component of chronic pain characterized by its rapid onset, intensity and relatively short duration. An estimated 800,000 cancer patients will experience breakthrough pain this year, based on data reported by the American Cancer Society.

“Our longer-term clinical strategy is focused on developing Fentora for patients with breakthrough pain associated with other conditions, including neuropathic pain and back pain,” said Frank Baldino, Cephalon chairman and chief executive, in a statement.

Cephalon will manufacture Fentora in five dosage strengths _ 100, 200, 400, 600 and 800 micrograms.

Under an agreement, the FDA approval allows Barr Laboratories to launch a generic version of Actiq, the painkiller Fentora is meant to replace.