Discovery Laboratories (DSCO) Submits Propsed Protocol for Surfaxin Clinical to U.S. FDA

November 17, 2009 7:31 AM EST

Discovery Laboratories, Inc. (NASDAQ: DSCO) announced today that it has submitted to the U.S. Food and Drug Administration (FDA) its proposed protocol for a Surfaxin (lucinactant) limited clinical trial. The protocol incorporates a clinical trial design that is primarily intended to assess a pharmacodynamic (PD) response following Surfaxin administration in preterm infants with Respiratory Distress Syndrome (RDS). Discovery Labs proposed this trial design in response to a comment by the FDA that a limited clinical trial could potentially resolve the key remaining issue for approval of Surfaxin for the prevention of RDS in premature infants.

Discovery Labs received a Complete Response Letter for Surfaxin in April 2009. At an end-of-review meeting with the FDA on June 2, 2009, the FDA suggested that, to increase the likelihood of gaining Surfaxin approval, Discovery Labs could consider conducting a limited clinical trial. On September 29, 2009, Discovery Labs held a teleconference with the FDA to discuss, among other things, whether a PD approach would satisfy the FDA's requirement for a limited clinical trial. Typically, PD-based clinical trials primarily assess short-term, physiologic responses to therapy and, therefore, are generally less expensive and of shorter duration than trials that have clinical outcomes as a primary endpoint. The FDA indicated that Discovery Labs' proposed concept of a PD trial design is acceptable and also provided direction regarding certain trial design specifics.

Employing the FDA's guidance, Discovery Labs worked closely with leading academic neonatologists to design the PD protocol. The final protocol and clinical trial design is subject to FDA review and comment. In accordance with the FDA's guidance, Discovery Labs expects to receive the FDA comments early in the first quarter 2010. At that time, Discovery Labs will be in a position to estimate the expected costs and duration of the trial and make a strategic assessment, with existing and potential new partners, regarding any investment in a potential limited clinical trial for Surfaxin for RDS.

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