October 6, 2009 - 5:03am
Has anyone found anymore information after Abbotts press release of the phase III trials of Vicodin CR???
October 6, 2009 - 8:35am
#2
It
It seems that any medicine now-a-days has a CR counterpart. This would just complete the puzzle, I think. Did they say when or how soon this would happen??
October 6, 2009 - 2:28pm
#3
They submited there NDA in
They submited there NDA in late 07 got reviewed mid-late 08 and did not get approval but did get a complete response letter which basically means the med is approvable but needs either more testing, prescribing info change, dosage changed, non clinical testing, etc. The FDA replaced the Approvable Drug letter to Complete Response Letter, they also have Approved and Denied Letters. Now its up to abbott whether or not they want to keep pumping money into a med that already has a saturated competition market with generic non cr hydrocodone. With strengths of hydro/apap at 15/500 and 30/500 who would pay a huge brand name price when you can just take a couple extra generic IR pills a day or probably still under the cost of name brand vicodin cr get hydrocodone pills custom compounded without apap in them. Now without the apap abbott could have a blockbuster pain med with vicodin cr.
October 6, 2009 - 2:33pm
#4
Oh yea, Brandon, Hydrocodone
Oh yea, Brandon, Hydrocodone and Morphine are equipotent when taken orally. IMHO mg vs mg Hydrocodone is actually stronger than Morphine but since MHO doesnt count, they are equal. One thing I just noticed and what the FDA probably had a problem with is that the 15/500 would be CIII and the 30/500 would be CII, thats if the projected strengths Ive read about are true.
October 6, 2009 - 2:47pm
#5
Solo I agree with you now
Solo I agree with you now that I think of it. Ive always found morphine weak especially compared to OC. I think a lot of doctors do go from hydro to morphine though and consider it a graduation. Not that they have any personal experience or even know what they are talking about. Thank you for the update on Vicodin CR and you are also right in that they should be concentrating a formulation without APAP, although with the doses you referred to, using it BID would be a huge reduction in APAP over multiple dosages of IR hydro.
I think this is good news for less tolerant people. It will add another step before having to graduate to oxy or morphine.