Discovery Laboratories, Inc.
DSCO, a specialty biotechnology company dedicated to advancing a
new standard in respiratory critical care, today announced that on June 7,
2013 it submitted a response to the U.S. Food and Drug Administration's
(FDA) recent correspondence relating to Discovery Labs' recently updated
product specifications for SURFAXIN(R) . Discovery Labs expects that the
FDA may take up to four months to review the information provided. If its
plan is successful and the FDA agrees with the response, Discovery Labs
expects to proceed with the commercial introduction of SURFAXIN in the
fourth quarter of 2013.
In the third quarter of 2012, during a routine review of the results and
processes related to the analytical testing and quality control of SURFAXIN
drug product, Discovery Labs determined that one of its analytical chemistry
methods used to assess SURFAXIN drug product conformance to specifications
required improvement and that an update to product specifications was
necessary. The Company proactively communicated these findings to the FDA,
improved and revalidated the analytical chemistry method, and submitted
updated product specifications to the FDA. Subsequently, the FDA requested
information and provided recommendations intended to clarify certain aspects
of the updated product specifications and the revalidated analytical
chemistry method. Discovery Labs has now responded to the FDA's request.
Improvement of the method and the proposed change in SURFAXIN product
specifications is expected to have no impact on Discovery Labs' development
programs, including AEROSURF(R) . The AEROSURF program currently remains on
track for the initiation of phase 2 clinical program in the fourth quarter
of 2013.
ABOUT SURFAXIN(R) SURFAXIN (lucinactant) Intratracheal Suspension is a
synthetic, peptide-containing surfactant. SURFAXIN is indicated for the
prevention of respiratory distress syndrome (RDS) in premature infants at
high risk for RDS. The safety and efficacy of SURFAXIN for the prevention of
RDS in premature infants was demonstrated in a large, multinational phase 3
clinical program that included 1294 patients.
IMPORTANT SAFETY INFORMATION
SURFAXIN is intended for intratracheal use only. The administration of
exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation
and lung compliance. SURFAXIN should be administered only by clinicians
trained and experienced with intubation, ventilator management, and general
care of premature infants in a highly supervised clinical setting. Infants
receiving SURFAXIN should receive frequent clinical assessments so that
oxygen and ventilatory support can be modified to respond to changes in
respiratory status.
Most common adverse reactions associated with the use of SURFAXIN are
endotracheal tube reflux, pallor, endotracheal tube obstruction, and need
for dose interruption. During SURFAXIN administration, if bradycardia,
oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs,
administration should be interrupted and the infant's clinical condition
assessed and stabilized.
SURFAXIN is not indicated for use in acute respiratory distress syndrome
(ARDS).
For more information about SURFAXIN, please visit www.surfaxin.com.
ABOUT AEROSURF(R) AEROSURF (lucinactant for inhalation), Discovery Labs'
aerosolized KL4 surfactant product, is under development to address
respiratory distress syndrome in premature infants. Through the effective
delivery of aerosolized KL4 surfactant using Discovery Labs' proprietary
capillary aerosol generator technology, AEROSURF may significantly expand
the surfactant-eligible treatment population by providing neonatologists
with a means of administering surfactant without the risks currently
associated with invasive endotracheal intubation and mechanical ventilation.
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