Shares of Adolor took off this morning, climbing 18 percent after the company issued a joint release with GlaxoSmithKline that the FDA had accepted their response to the agency's approvable letter [1]Â for the constipation drug Entereg (alvimopan). The FDA had placed the trials on clinical hold and asked for more data [2]. The companies are waiting on a request to lift the clinical hold so they can resume trials.
"The FDA informed Adolor that the response is considered a complete class 2 response with a Prescription Drug User Fee Act (PDUFA) goal date of February 10, 2008," according to the release.
- see the release [3]
- read the report [4] from Hemscott
Related Articles:
FDA wants more safety data on Entereg. Report [2]
Adolor shelves Entereg studies; shares plunge. Report [5]
FDA needs more data on Adolor drug. Report [6]
Adolor hit by FDA's approvable letter for Entereg. Report [1]
Adolor shares in meltdown on trial data. Report [7]
Links:
[1] http://www.fiercebiotech.com/story/adolor-hit-by-fda-s-approvable-letter-for-entereg/2006-11-06
[2] http://www.fiercebiotech.com/story/fda-wants-more-safety-data-on-entereg/2007-06-11
[3] http://www.fiercebiotech.com/press-releases/press-release-fda-accepts-review-complete-response-approvable-letter-entereg-poi
[4] http://www.hemscott.com/news/latest-news/item.do?newsId=48500918895874
[5] http://www.fiercebiotech.com/story/adolor-shelves-entereg-studies-shares-plunge/2007-04-10
[6] http://www.fiercebiotech.com/story/fda-needs-more-data-on-adolor-drug/2005-07-22
[7] http://www.fiercebiotech.com/story/adolor-shares-in-meltdown-on-trial-data/2006-09-05