Results from pain-patch test boost BDSI

On a day that Wall Street toasted a new trading record, a little-known Morrisville company with an experimental pain patch was one of the market's biggest celebrants.

Shares of BioDelivery Sciences International surged 30 percent Wednesday after the company reported that its Bema Fentanyl patch is an effective and more convenient option to existing treatments.

By the close of trading, 13.9 million shares of BDSI had changed hands -- 100 times the number traded on an average day. The stock closed at $6.05, up $1.41.

"That's a lot," said Barry Teater, an N.C. Biotechnology Center spokesman, calling BDSI's test results "astounding."

BDSI had the second-largest gain among stocks traded on the New York Stock Exchange and Nasdaq on a day when a flurry of better-than-expected earnings had Wall Street roaring. The surge added about $30 million to the market value of the 15-employee company, which was founded in 2003 as Arius Pharmaceuticals.

What fanned the excitement is BDSI's promise to provide a more convenient way to administer drugs that have to work quickly, such as intravenous pain relief and oral antinausea medications.

"This is a new technology, and people were waiting to see the [test] results," said Mark Sirgo, BDSI's chief executive.

Bema Fentanyl attaches to the inside of the mouth and contains fentanyl, a narcotic painkiller. The patch is designed to help cancer victims, people coming out of surgery and emergency room patients.

Speeding pain relief

Fentanyl is known to quickly reduce the intense pain patients experience. But it is only available as an intravenous infusion.

A patch would be more convenient and would allow patients taking the painkiller to leave the hospital more quickly. Bema Fentanyl has the potential to generate up to $250 million in annual sales, Sirgo said.

But to have a chance of receiving regulatory approval, BDSI had to show that the fentanyl on the patch passes through the mucous membranes on the inside of the mouth rapidly and reliably and is quickly distributed throughout the body.

Wednesday's test results did just that. The 80 patients who participated in the late-stage study reported that Bema Fentanyl reduced their pain within 30 minutes. BDSI reported that Bema Fentanyl was well tolerated by the patients in the study.

The company is waiting for results from an ongoing study analyzing potential side effects. It expects to request regulatory approval for Bema Fentanyl in the third quarter. BDSI, which is looking for a marketing partner, hopes to have the patch on the market next year.