Scientists say they "serendipitously" discovered that a drug …
In a very small group of patients, sending electrical impulses …
Advertisement
Respiratory drug review could speed up
Maker says no new clinical trials necessary
Updated: Tuesday, 16 Feb 2010, 4:36 PM EST
WARRINGTON, Pa. (AP) - Discovery Laboratories Inc. said Tuesday it won't have to run new clinical trials of its respiratory stress syndrome treatment Surfaxin, which could save the company money and help get the drug approved sooner.
After discussions with the Food and Drug Administration, Discovery Labs said it will focus on testing the drug on prematurely born lambs instead of premature infants. The FDA has been reviewing Surfaxin since 2006, and the process has stalled over concerns about the test used to determine its shelf life and manufacturing issues.
The company based its comments on written guidance from the agency. Discovery Labs said the animal trials will take less time and money than testing the drug on humans. It said it could send the FDA a response by March 2011.
Ground rules for posting comments: No profanity or personal attacks. No racially charged comments. If it's not something you would say to someone's face, it's most likely inappropriate. Please comment on the subject of the story itself. If you do not follow these rules, we will remove your post. Repeat offenders will be banned from making future comments. Keep it civil, folks! WANE is not responsible for the content posted in this comment section.
Email This
Print This
View Story on a Single PageAdvertisement
Advertisement