SurfaxinTreatment for Respiratory Distress Syndrome
Update: Surfaxin (lucinactant) Now FDA Approved - March 6, 2012
Discovery Laboratories Announces FDA Acceptance of Surfaxin New Drug Application
DOYLESTOWN, Pa., June 15, 2004 -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that the United States Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) filing for Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The FDA has granted a Standard Review designation and has established a target date of February 13, 2005 for completion of review of the Surfaxin NDA.
Christopher J. Schaber, Ph.D., Executive Vice President and Chief Operating Officer of Discovery, stated, "We believe the data included in the NDA strongly supports the therapeutic benefit of Surfaxin for patients who suffer from RDS. Surfaxin, if approved, has the potential to set a new standard for the prevention of RDS and would begin a dramatic evolution in the use of engineered humanized surfactants for the treatment of serious and life-threatening respiratory diseases prevalent in the neonatal intensive care unit. Surfaxin serves as the cornerstone of our portfolio of Surfactant Replacement Therapies to treat various respiratory diseases. We will continue to work closely with the FDA to facilitate a thorough and proper review of our NDA."
The NDA filing was supported, in large part, by data from Discovery's two positive Phase 3 RDS clinical trials. The first was a landmark, 1,294 patient pivotal study that demonstrated Surfaxin's superiority to Exosurf(r), a non-protein containing synthetic surfactant. Survanta(r), a cow-derived surfactant and the leading surfactant used in the United States, served as a reference arm in the trial. The second trial was a 252 patient supportive study that demonstrated Surfaxin's non-inferiority to Curosurf(r), a pig-derived surfactant and the leading surfactant used in Europe.
Discovery also is preparing a Marketing Authorization Application (MAA) to be filed with the European Medicines Evaluation Agency (EMEA) in the second half of 2004 for Surfaxin for the prevention and treatment of RDS.
About Discovery Laboratories
Discovery Laboratories, Inc. is a biopharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases. Surfactants are compositions produced naturally in the lungs and essential for breathing. Discovery's technology produces an engineered version of natural human lung surfactant that is designed to closely mimic the essential properties of human lung surfactant. Discovery believes that through its technology, pulmonary surfactants have the potential, for the first time, to be developed into a series of respiratory therapies for critical care and other hospitalized patients where there are few or no approved therapies available.
Discovery has filed a New Drug Application with the FDA for clearance to market Surfaxin, the Company's lead product, for the prevention of Respiratory Distress Syndrome in premature infants. Discovery is also conducting a Phase 2 clinical trial for Acute Respiratory Distress Syndrome in adults, Phase 3 and Phase 2 clinical trials for Meconium Aspiration Syndrome in full-term infants and (with aerosolized surfactant) is preparing to initiate a Phase 2 trial for asthma (development name DSC-104) and a Phase 2 trial for Respiratory Dysfunction in premature infants.
More information about Discovery is available on the Company's Web site at www.DiscoveryLabs.com.
Posted: June 2004
- Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome - March 6, 2012
- Discovery Labs Notified of PDUFA Date for Surfaxin - October 12, 2011
- Discovery Labs Submits Surfaxin Complete Response to FDA - September 6, 2011
- Discovery Labs Provides Expanded Update Regarding Its Program for Surfaxin U.S. Marketing Authorization - February 1, 2011
- Discovery Labs Provides Update Regarding Its Program for Surfaxin U.S. Marketing Authorization - January 10, 2011
- Discovery Labs Receives FDA Guidance Regarding Preclinical Program to Gain Surfaxin Approval - June 8, 2010
- Discovery Labs Achieves Key Milestone Towards Potential Surfaxin Approval - May 19, 2010
- Discovery Labs and FDA Establish Path for Potential Surfaxin Approval - October 2, 2009
- Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for Surfaxin Approval - September 11, 2009
- Discovery Labs Reports On Surfaxin End of Review Meeting With FDA - July 2, 2009
- Discovery Labs and FDA to Meet On June 2, 2009 to Discuss Surfaxin Complete Response Letter - May 12, 2009
- FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin - November 10, 2008
- Discovery Labs Submits Complete Response to May 2008 FDA Approvable Letter for Surfaxin for RDS - October 20, 2008
- Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin - September 24, 2008
- Discovery Labs Reports Progress in Responding to Surfaxin FDA Approvable Letter - August 6, 2008
- Discovery Labs and FDA Meet to Clarify Limited Items in Surfaxin Approvable Letter - June 19, 2008
- Discovery Labs and FDA to Meet On June 18, 2008 to Clarify Limited Items in Surfaxin Approvable Letter - May 29, 2008
- Discovery Labs Provides Guidance On FDA Approvable Letter for Surfaxin for RDS - May 5, 2008
- Discovery Labs Receives An Approvable Letter From FDA for Surfaxin for RDS - May 2, 2008
- Discovery Labs' Response to Surfaxin Approvable Letter Deemed Complete by FDA - November 16, 2007
- Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - November 1, 2007
- Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter - October 1, 2007
- Discovery Labs Provides Update On Progress for Surfaxin for RDS - August 2, 2007
- Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval - January 22, 2007
- Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters - September 28, 2006
- Discovery Labs Receives Second Approvable Letter From FDA for Surfaxin for RDS - April 5, 2006
- FDA Accepts Discovery Labs' Complete Response to Approvable Letter for Surfaxin - October 21, 2005
- Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin - August 19, 2005
- Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin - August 15, 2005
- Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - July 29, 2005
- Discovery Labs Receives Approvable Letter from FDA for Surfaxin for Respiratory Distress Syndrome in Premature Infants - February 14, 2005
- Discovery Laboratories Files New Drug Application with the FDA to Market Surfaxin for the Prevention of Respiratory Distress Syndrome in Premature Infants - April 14, 2004