Discovery Laboratories, Inc. has announced that it has received guidance from the FDA in a recent meeting regarding the key remaining steps necessary for potential approval of Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The guidance provides the clarity and the defined pathway that Discovery believes is necessary to address key remaining issues identified in the April 2006 FDA Approvable Letter. Discovery anticipates filing its formal response to the Approvable Letter in September or October 2007, followed by a six-month review cycle by the FDA for potential approval of its New Drug Application (NDA) for Surfaxin.
The guidance was based on a face-to-face meeting with the FDA on December 21, 2006 as well as the FDA's review of the meeting briefing package submitted by Discovery on September 28, 2006:* The defined pathway to potential Surfaxin approval does not include a requirement for additional clinical trials.* The April 2006 Approvable Letter primarily focused on the Chemistry, Manufacturing and Controls (CMC) section of the Surfaxin NDA and requested additional information predominantly involving drug product specifications and related controls. With the clarity gained at the FDA meeting, Discovery expects to provide all of the necessary additional information in its formal response to the Approvable Letter.* Discovery provided information to the FDA regarding its comprehensive investigation and remediation of the April 2006 Surfaxin process validation stability failure including the identification of a most probable root cause. The comprehensive investigation focused on analysis of manufacturing processes; analytical methods and method validation; and active pharmaceutical ingredient suppliers.
Consistent with Discovery's proposal included in the FDA meeting briefing package, Discovery is planning to initiate the manufacture of new Surfaxin process validation batches soon and will submit six months of related stability data in its forthcoming formal response to the Approvable Letter. Additionally, the FDA indicated that Surfaxin shelf-life will be determined based upon comparative stability data from historical Surfaxin batches, including previously manufactured clinical, technology transfer, and investigational batches, as well as the new process validation batches.
Robert J. Capetola, Ph.D., President and Chief Executive Officer of Discovery, commented, "The encouraging outcome of this important FDA meeting is a reflection of the leadership and efforts of our team of regulatory, manufacturing and quality executives. This executive team is also responsible for improving and enhancing the manufacturing operations that we acquired from our then contract manufacturer. With the clarity gained from the FDA meeting, the top priorities now are completing the necessary work to submit our response to the FDA for Surfaxin approval, and advancing Aerosurf, our aerosolized surfactant therapy, into Phase 2 clinical trials."