http://www.pharmalot.com/2008/01/fda-panel-endorses-glaxo-bowel-drug/ News, Comment and Conversation Fri, 10 Feb 2012 20:00:06 +0000 http://wordpress.org/?v=2.6.2 http://www.pharmalot.com/2008/01/fda-panel-endorses-glaxo-bowel-drug/#comment-111313 ol cranky Thu, 24 Jan 2008 02:25:46 +0000 http://www.pharmalot.com/2008/01/fda-panel-endorses-glaxo-bowel-drug/#comment-111313 Taking a look of the POI studies in total (completely ignoring the OBD debacle) which were a mixed bag of positive and negative in terms of efficacy, I am disturbed that a gastroenterologist thinks it worthwhile to approve after making the statement that "the benefits MARGINALLY overcome the negative" [emphasis added]. The drug would likely be used prophylactically in a lot of simple hysterectomies with minimal bowel manipulation and, therefor, minimal problems with ileus that doesn't usually extend hospital stay. While the CV side effects are unlikely to present a significant problem with acute administration in a post-op population, the benefit (including cost savings) is admittedly minimal so why bother? Adolor needs this approval for marquee value as they screwed up the most of the trials for this compound over the past 8 years but, considering the company was unable to get investigators to adhere to the protocol way too often, I don't really trust them to educate physicians to be judicious in the use of the compound. Taking a look of the POI studies in total (completely ignoring the OBD debacle) which were a mixed bag of positive and negative in terms of efficacy, I am disturbed that a gastroenterologist thinks it worthwhile to approve after making the statement that “the benefits MARGINALLY overcome the negative” [emphasis added]. The drug would likely be used prophylactically in a lot of simple hysterectomies with minimal bowel manipulation and, therefor, minimal problems with ileus that doesn’t usually extend hospital stay. While the CV side effects are unlikely to present a significant problem with acute administration in a post-op population, the benefit (including cost savings) is admittedly minimal so why bother? Adolor needs this approval for marquee value as they screwed up the most of the trials for this compound over the past 8 years but, considering the company was unable to get investigators to adhere to the protocol way too often, I don’t really trust them to educate physicians to be judicious in the use of the compound.

]]> http://www.pharmalot.com/2008/01/fda-panel-endorses-glaxo-bowel-drug/#comment-111261 Laurie Thu, 24 Jan 2008 00:26:00 +0000 http://www.pharmalot.com/2008/01/fda-panel-endorses-glaxo-bowel-drug/#comment-111261 Early ambulation post operatively will take care of this in most cases with no cardiac risk. Early ambulation post operatively will take care of this in most cases with no cardiac risk.

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