BioDelivery's trial of pain patch reaches main goal
Last Updated: 2007-04-25 12:01:14 -0400 (Reuters Health)
BANGALORE (Reuters) - BioDelivery Sciences International Inc. said a late-stage trial of its patch to treat severe, or "breakthrough," pain linked with cancer met its main goal, sending its shares up 63 percent in pre-market electronic trade on Wednesday.
BioDelivery said the product, BEMA Fentanyl, produced a statistically significant reduction in pain at 30 minutes compared with a placebo.
"Breakthrough" pain in cancer relates to episodes of severe pain that break through medication used to control persistent pain.
If approved, BioDelivery's product will compete with market leader Cephalon Inc.'s lozenge Actiq and tablet Fentora, both fentanyl-based products for the treatment of breakthrough cancer pain.
According to BioDelivery, franchise sales for Cephalon in rapid acting fentanyl products were $659 million in 2006.
BioDelivery Chief Executive Mark Sirgo said by phone the company expects sales of the BEMA Fentanyl product, the most advanced in the company's pipeline, to reach $250 million in the third full year after approval.
The company said a safety study of the patch is ongoing and the results, along with Wednesday's efficacy results, will form the basis of a new drug application (NDA) to U.S. regulators.
Sirgo said the company plans to file the NDA in the third quarter of 2007.
There were no drug-related changes to the oral mucosa, or mucous membrane in the mouth, for patients in the trial, the company said, which is important for cancer patients who may also have oral ulcerations as a result of a weakened immune system.
Eighty patients took part in the portion of the study concerned with the main goal, BioDelivery said.
BEMA Fentanyl works as a combination of the company's BEMA technology, a small, oral adhesive disc applied to the inner cheek lining, and the drug fentanyl. The disc sticks to the inside of the cheek and delivers the medication, after which it disintegrates in the mouth, leaving no drug residue.
Shares of BioDelivery rose to $7.59 in pre-market trade, after closing at $4.64 Tuesday on the Nasdaq. At that time, no movement was seen in Cephalon shares.
