Discovery Could Move Ahead With Surfaxin Program

WARRINGTON, Pa. (AP) — Discovery Laboratories Inc. said Wednesday it may be able to move forward with its long-delayed drug candidate Surfaxin, following discussion with the Food and Drug Administration.

Surfaxin is aimed at treating respiratory distress syndrome in infants, and has faced long delays in the FDA regulatory process because of requests for more information from the company. The last request focused on the test used to determine the drug's shelf-life and whether the commercial product would be comparable to the product used in the studies.

Discovery said a meeting with the FDA focused on the shelf-life issue and a proposed limited Surfaxin study that would use a new design. The FDA indicated that Discovery Labs' proposed program to optimize and validate the BAT is reasonable, Discovery said.

The company said it believes it reached an understanding with the FDA and is confident that it will be able to move forward, aiming for a protocol submission to the FDA in the fourth quarter.

Shares of Discovery Laboratories skyrocketed 51 cents, or 46 percent, to $1.62 in premarket trading.