Cephalon Inc. reported positive data from a third Phase III trial of Fentora in non-cancer breakthrough pain, and plans to file for approval in that broader indication later this year.

The product, a fentanyl buccal tablet, was approved late last year for use in opioid-tolerant cancer patients who experience breakthrough pain despite their existing opioid therapy. Frazer, Pa-based Cephalon reported second-quarter Fentora sales of $36.3 million.

The newly reported study demonstrated statistically significant improvements in pain intensity vs. placebo in a trial that included 148 patients with a range of chronic non-cancer pain conditions. The first two Phase III trials demonstrated efficacy in treating breakthrough pain associated with chronic low-back pain and chronic neuropathic pain.

Stacey Beckhardt, associate director of product communications at Cephalon, said the company intends to submit a supplemental new drug application in the fourth quarter, although she did not speculate on the specific labeling that would be sought.

"We are very pleased to see efficacy in a broad range of non-cancer conditions," Beckhardt told BioWorld Today. "The important thing is we have now conducted a study that included a broad variety of chronic pain conditions in a controlled clinical trial. Right now we are releasing top-line data indicting we have met primary endpoint."

She said this was the first trial of its sort in breakthrough pain outside the cancer setting.

Patients served as their own controls, getting placebo or Fentora when having episodes of breakthrough pain. That pain is a component of chronic pain characterized by its rapid onset of a few minutes, its intensity, and its relatively short duration of 30 to 60 minutes. Patients already were taking an opioid therapy for control of their underlying persistent pain.

The primary endpoint of the double-blind, variable-dose Phase III trial was the Sum of Pain Intensity Differences from five to 60 minutes after treatment, as assessed after 12 weeks of treatment. The trial showed statistically significant improvements (p<0.0001).

Fentanyl, an opioid agonist, is a Schedule II controlled substance. Beckhardt said efficacy was shown regardless of which pain drug the patient already was taking.

Cephalon could use a boost in its pain franchise, as Actiq, another fentanyl-based product, recently became subject to generic competition. Sales of Actiq for the first six months of this year decreased to $130 million from $290 million in the first half of 2006.

Beckhardt said Fentora, a tablet that dissolves in the back of the mouth, has some advantages to Actiq, a lozenge formulation on a handle that patients rub on the insides of their cheeks. One, she said, is that Fentora has bioavailability advantages. Another, she said, is that passive rather than active treatment is preferable. She also said some patients did not like the handle.

Cephalon got Fentora, then known as OraVescent fentanyl, through its acquisition of Eden Prairie, Minn.-based CIMA Labs Inc., a deal that closed in August 2004. Cephalon already was selling Actiq, which it had acquired a few years earlier.

In March, Cephalon filed for European approval of Fentora for breakthrough pain in cancer patients. Other recent news at Cephalon included the approval of Nuvigil, a single-isomer formulation of modafinil, the active ingredient in Cephalon's sleepiness drug Provigil. And Cephalon is planning separate new drug application filings this year seeking approval of Treanda (bendamustine) for treating chronic lymphocytic leukemia and indolent non-Hodgkin's lymphoma.

Cephalon's product sales were $859 million for the first six months of the year, with total revenues of $884 million. The comparable year-ago numbers were $776 million and $797 million, respectively.

Cephalon's stock (NASDAQ:CEPH) fell $1.18 Thursday to close at $67.66.

No Comments