Discovery faces further FDA delays on Surfaxin

WARRINGTON, Pa. - Discovery Laboratories Inc. said Wednesday the Food and Drug Administration will apply a new standard to the company's respiratory drug candidate application, likely further holding up approval.

The company has been trying to gain approval for Surfaxin, aimed at treating respiratory distress syndrome in infants. The FDA has made several 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.

At a June 2 meeting, Discovery said the FDA will apply a new standard to determine whether the company has demonstrated comparability.

"This new standard represents a significant hurdle for approval of Surfaxin," the company said, in a statement. "Discovery Labs believes that the information provided to the FDA for the meeting demonstrates comparability and supports Surfaxin approval."

In light of the new standard, though, the company said it is unlikely to satisfy the requirement with existing data and gain approval soon.

The company is determining its next move, which could include more discussions with the FDA or a possible appeal.

Meanwhile, the company said it seems more prudent to shift its focus on potential aerosolized treatments for the condition. It already has ongoing studies with that focus.

Shares of Discovery Laboratories fell 12 cents, or 11 percent, to 94 cents in after-hours trading.

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