Four months after reporting positive Phase III results, Cephalon Inc. filed for regulatory approval of its OraVescent fentanyl tablet to treat breakthrough pain in cancer patients.

If approved, the product would complement Cephalon's already-approved Actiq, another fentanyl-based product. Both Actiq and OraVescent fentanyl (OVF) are administered through transmucosal delivery, though Actiq is applied as a lozenge on a handle, while OVF was developed as an effervescent buccal tablet using a delivery technology developed by Cephalon's subsidiary, CIMA Labs Inc.

The OraVescent technology "takes advantage of fentanyl's ability to be absorbed through the oral mucosa into the bloodstream," said Stacey Beckhardt, spokeswoman for Cephalon. "The tablet is put in the mouth, against the lining of the mouth, and then it dissolves through the inner lining of the cheek," a process that takes about 15 minutes.

Existing treatments for breakthrough pain, which is described as a sudden flare of pain that interrupts the relief provided by around-the-clock medication, often take about 30 to 45 minutes to be absorbed into the bloodstream

The new drug application for OVF contained results from 13 studies, including a 123-patient pivotal Phase III study that showed statistical significance of OVF over placebo. Patients who received OVF reported significant improvements on the primary endpoint, a measure of the Sum of Pain Intensity Difference scale. (See BioWorld Today, May 6, 2005.)

Cephalon anticipates the FDA will accept the NDA filing for review within 60 to 90 days, and expects an action letter during the third quarter of 2006, Beckhardt said. The company is seeking approval in multiple dosage strengths - 100 mg, 200 mg, 400 mg, 600 mg and 800 mg - and the medication would be listed as a Schedule II controlled substance.

"The problem of breakthrough pain is a huge one," Beckhardt told BioWorld Today. "It's an area where we see a tremendous patient need."

Of the U.S. cancer population, she estimates that about 800,000 suffer from breakthrough pain.

Cephalon will market OVF itself and has plans to establish a separate pain care sales force that also would handle Actiq, which recorded revenue of $91.8 million during the second quarter. That sales team would be "a group of about 100 representatives, drawn from our existing sales force, as well as some new hires," Beckhardt said.

The OVF application is the third regulatory filing Cephalon has completed during the past year. In December, the company submitted a supplemental NDA for Attenace (modafanil) tablets for the treatment of attention deficit hyperactivity disorder in children and adolescents, and followed in March with an NDA for Nuvigil (armodafinil) tablets for excessive sleepiness. Cephalon also awaits the FDA's decision on naltrexone long-acting injection for the treatment of alcohol dependence. The drug was developed by Cambridge, Mass.-based Alkermes Inc., which entered an agreement with Cephalon to develop and commercialize the product.

Meanwhile, Cephalon's Gabitril (tiagabine) is nearing its filing date. The product is in a Phase III trial in patients suffering from generalized anxiety disorder.

"We've really got some wonderful opportunities going on right now," Beckhardt said. "We're seeing a lot of growth across the board."

Shares of Cephalon (NASDAQ:CEPH) rose 1 cent Tuesday to close at $42.05.

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