| Add to balance / Manage account | User: | Log out |
| Prospect News home > News index > List of issuers D > Headlines for Discovery Laboratories Inc. > News item |
Discovery Laboratories ends phase 2 trial of Surfaxin early
New York, May 9 - Discovery Laboratories, Inc. said it has decided to end early its phase 2 trial of Surfaxin for the prevention and treatment of bronchopulmonary dysplasia in premature infants.
The decision was taken on Tuesday, at which point 130 patients had been enrolled. The company had originally intended to include 210 very low birth weight premature infants born at risk for developing respiratory distress syndrome.
Discovery said it took the decision because of the potential financial impact of manufacturing issues with Surfaxin that are anticipated to significantly delay the regulatory approval of Surfaxin for respiratory distress syndrome and may adversely affect the availability of Surfaxin for the current trial.
On May 4, the company announced it was cutting its workforce by 55 employees or 34% and reorganizing its corporate management in order to cut costs and align operations with its business properties, again because of the problems with Surfaxin.
The phase 2 study is intended to determine the safety and tolerability of administering Surfaxin for the prevention and treatment of bronchopulmonary dysplasia.
Discovery said it will analyze the clinical data, report top-line results and submit the data for publication.
As previously announced, in April Discovery received a second approvable letter from the Food and Drug Administration for its New Drug Application for Surfaxin.
The letter focused on the chemistry, manufacturing and controls section of the application and product labeling.
Discovery also announced that it anticipated a potentially significant delay in Surfaxin approval due to the failure of certain stability parameters for process validation batches that were previously manufactured as a requirement for regulatory approval.
Discovery is a biotechnology company developing surfactant technology for respiratory diseases and is located in Warrington, Pa.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.