Adolor and GlaxoSmithKline have revealed that the FDA is looking for more safety data along with new results for carcinogenicity for the experimental Entereg. The data requests are a condition for the agency's approval to use Entereg as a treatment for post-surgery bowel dysfunction. Originally, Entereg was in trials for opiate-induced constipation, a much larger indication. But those studies were suspended after researchers determined the drug was linked to higher rates of cardiovascular incidents, fractures as well as skin cancers. New data is expected in the third quarter.
- see this release [1] on Entereg
- read the AP report [2]
Related Articles:
Adolor shelves Entereg studies; shares plunge. Report [3]
FDA needs more data on Adolor drug. Report [4]
Adolor hit by FDA's approvable letter for Entereg. Report [5]
Adolor shares in meltdown on trial data. Report [6]
Links:
[1] http://www.fiercebiotech.com/node/7200
[2] http://www.forbes.com/feeds/ap/2007/06/11/ap3807556.html
[3] http://www.fiercebiotech.com/story/adolor-shelves-entereg-studies-shares-plunge/2007-04-10
[4] http://www.fiercebiotech.com/story/fda-needs-more-data-on-adolor-drug/2005-07-22
[5] http://www.fiercebiotech.com/story/adolor-hit-by-fda-s-approvable-letter-for-entereg/2006-11-06
[6] http://www.fiercebiotech.com/story/adolor-shares-in-meltdown-on-trial-data/2006-09-05