New Injectable Drug for Colonoscopy Sedation In The Works

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   Posted 9/6/2008 10:12 AM (GMT -7)   
Fospropofol disodium injection is a proprietary water-soluble prodrug of propofol that, after intravenous injection, is converted by alkaline phosphatase in the body into propofol (also known as Diprivan). Fospropofol disodium injection is a product candidate in development for sedation of patients undergoing therapeutic or diagnostic procedures.
The U.S. FDA Advisory Committee on Anesthetic and Life Support Drugs (ALSDAC) has voted 6 to 3 in favor with one abstention of approval of fospropofol disodium injection for use as an intravenous sedative-hypnotic agent for sedation in adult patients undergoing diagnostic or therapeutic procedures.
The Committee recommended use of fospropofol disodium injection to healthcare providers who are appropriately trained. Further, the Committee recommended additional studies be conducted in specific patient populations, including those with a variety of comorbidities, for example, in patients who weigh less than 60 kg and the elderly.
21 clinical studies involving 1,611 individuals are included in the application. The clinical trials were conducted by nonanesthesia health care professionals and study drugs were administered by medical personnel.
The FDA is not bound by its Advisory Committees' recommendations.

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   Posted 9/6/2008 10:22 AM (GMT -7)   
Cool. Now, when are they going to develop a prep that doesn't leave us too sore to sit and shaking like leaves from diarrhea?

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   Posted 9/6/2008 10:25 AM (GMT -7)   
Hmmmmm . . . I was hoping it would be a sedation to get us through the dreaded PREP !!!


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   Posted 9/6/2008 7:19 PM (GMT -7)   
I have a horrible reaction to versed and refuse to have it again; would this be a good alternative?
49 y/o woman.  Diagnosed 4/06 after colonscopy, SBFT, CT-scan all showed crohns. 3 months later, after pred and remicade, all tests showed no crohns. December '06 had adhesions cut through a laparoscopy. Now taking Glycolax, Ultra Fiber Plus, Florastor, and DHEA. Have become gluten-free diet per naturopath's tests.

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   Posted 9/7/2008 12:01 AM (GMT -7)   
Not matter what they give me < I am always in sooo much pain during my colonoscopies. I think the problem is that they are doing so many in one day... they give you the sedation at the last minute in case the doctor is held up... but it doesn't really kick in until after the procedure is done. Hope this alternative works better.
51 yr.old retired RN,Crohn's D for last35 yrs..severe esophagitis, migraines,strictures,urethral stricture,depression,probable MS.,RLS, arthritis, PTSD ,general anxiety disorder.

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   Posted 9/7/2008 6:05 AM (GMT -7)   
If the Versed causes problems then a good alternative is Diprivan (propofol) but in most states this requires an anesthesiologist to administer the propofol which means it can't be used in many stand alone facilities and quite possibly means the procedure be done at a hospital outpatient endoscopy unit. It certainly is something to ask about.

I'm not quite sure just WHY they are so excited about this fospropofol as opposed to propofol.

Also - Versed admnistered too fast can cause an adverse reaction - I got agitated, then hostile, and the scope had to be withdrawn before completion of the procedure - yet if administered properly and slowly will do the job. IF not enough is administered pain is remembered. AND if the doctor is not skilled and willing to take the time to do the scope PROPERLY or is over enthusiastic about using the air to expand the colon for ease of passing the scope THAT is what causes the pain.

I don't know if there is ANY hope that they'll EVER develop a prep that doesn't lay you low sicker than a dog w/a burning tail!!!
Some people are like Slinkies... Not really good for anything, but they still bring a smile to your face when you push them down a flight of stairs.

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Date Joined Jul 2006
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   Posted 9/7/2008 7:45 AM (GMT -7)   
way cool.
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