Dated by a few months, but still good info to review as to potential IF stability issues have been resolved.
Discovery Laboratories, Inc. (NasdaqGM:DSCO - News) announces publication of the one-year follow-up results from its SELECT and STAR Phase 3 clinical trials for Surfaxin(r), in Pediatrics, the premier medical journal for pediatric healthcare practitioners. The long-term data from the SELECT and STAR trials concluded that Surfaxin demonstrated a statistically significant survival advantage relative to existing animal-derived surfactants, Survanta(r) and Curosurf(r). Surfaxin is pending approval and has received an Approvable Letter from the United States Food and Drug Administration (FDA) for the prevention of RDS in premature infants.
The article published in Pediatrics is entitled: One-Year Follow-up of Very Preterm Infants Who Received Lucinactant for Prevention of Respiratory Distress Syndrome: Results from 2 Multicenter Randomized, Controlled Trials (Moya et al.) Pediatrics Vol. 119 No. 6 June 2007.
Fernando Moya, M.D., Chair of the SELECT study Steering Committee and Director of Neonatology at the Coastal Area Health Education Center, North Carolina, commented, ``The long-term outcomes from the pooled analysis are particularly important because they suggest that a next-generation surfactant therapy, such as Surfaxin, may save more babies' lives while improving their chances for a healthy future. The prospective assessment of long-term outcomes from the SELECT and STAR trials is unique given direct comparisons between surfactant products. The data set from this recently published analysis sets a new bar for this category.''
Key Data Highlights:
* Treatment with Surfaxin significantly improved survival (p=0.05)
through one-year of life compared with animal-derived surfactants,
Survanta and Curosurf.
* Surfaxin significantly improved survival (p=0.04) through one-year
of life when directly compared with Curosurf, the current market
leader in Europe and current market growth driver in United States.
* Although treatment with Surfaxin improved survival in preterm
children, no differences in neurologic outcomes through one-year of
life were observed between treatment groups, however, Surfaxin
demonstrated a statistically significant (p less than or equal to 0.05)
reduction in two important assessments of neurologic outcomes (reflex
abnormality and gross tone) versus Survanta. |
