Manufacturing Issues Cause Surfaxin's Fourth Failure to Receive FDA Approval

In its latest setback, Discovery Labs (Warrington, PA) has failed to receive FDA approval for the fourth time for Surfaxin (lucinactant). Discovery Labs has been seeking approval for Surfaxin, developed for the prevention of respiratory distress syndrome in premature infants, since 2004. In a Complete Response Letter dated April 17, 2009, the FDA expressed concern about a biological activity test (BAT), which is used as a stability and release test. The results of this test must be addressed before Surfaxin can be approved.

The FDA has questioned whether the BAT can distinguish degradation in the Surfaxin drug product over time and whether Discovery Labs has adequately validated the BAT and determined full acceptance criteria. Validation of the BAT would confirm the comparability of Surfaxin used in the clinical trials to the commercialized product.

Discovery Labs believes that it has already provided the necessary data to support the comparability of Surfaxin clinical drug product to Surfaxin commercial drug product and that the BAT can distinguish degradation over time. The company plans to seek an end of review meeting with the FDA as soon as possible.

The company is struggling to hold on. It is currently cash-strapped and is exploring potential business alliances, partnerships, and other opportunities.