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LUNG SURFACTANT CLINICAL STUDIES SHOULD ADDRESS PULMONARY FUNCTION

Executive Summary

LUNG SURFACTANT CLINICAL STUDIES SHOULD ADDRESS PULMONARY FUNCTION improvement as an efficacy endpoint when treating infant respiratory distress syndrome, outside panelist Donald Shapiro, MD, University of Rochester, suggested to FDA's Pulmonary-Allergy Advisory Committee Oct. 22. Asked by a member of the audience about the panel's consensus concerning endpoints in trials, Shapiro said: "I believe it is necessary for a surfactant to demonstrate a short-term improvement in pulmonary function." Shapiro maintained that if a study involving multiple doses over a prolonged period of time has a positive impact on the disease, "the infant is going to end up in better condition with less lung disease and a better neurologic outcome and a higher survival." He continued: "I'm not sure at this point -- because there's not enough data -- whether we should wait absolutely for the proof of those findings based on multiple dose trials." The advisory committee heard from a four-member panel of consultants on lung surfactants for treating infant respiratory distress syndrome, which usually affects infants with low birth weight. Shapiro told the committee it would be difficult to analyze the results of trials to date because "the noise is enormous in the data so far." Shapiro continued: "This is such an important issue . . . for child health in general that the National Institutes of Health and a number of major pharmaceutical firms are actively supporting very large clinical trials." Shapiro predicted that within two years there would be sufficient data "to draw meaningful conclusions." Panel member T. Allen Merritt, MD, University of California, San Diego, said that the panel should arrive at a "sense of efficacy" and decide whether "neonatal survival is necessarily the only point of efficacy." He added: "I believe it is an important one but not the only one." Mary Ellen Avery, MD, Harvard Medical School and also a member of the panel, pointed to duration of a hospital stay as an important end-point in assessing clinical efficacy. Merritt mentioned several surfactant products in clinical trials, including Buffalo, N.Y.-based ONY's InfraSurf and Burroughs-Wellcome's Exosurf. In addition, Merritt remarked that studies of Abbott's surfactant TA have been extended for respiratory distress syndrome treatment in a group of 84 infants. Abbott earlier said it would file an NDA in 1987 ("The Pink Sheet" March 16, "In Brief").
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