文档介绍：FDA
Anesthetic life Support Drugs
Advisory Committee
Art Van Zee. mD
St charles clinic
St charles. Va
Susstained-release hydromorphone
(Palladone)
Risks vs, benefits discussion
Benefits
Review
sustained release opioids vs
IR opioids
IR oXycodone vS Cr oxycodone
Comparable
Efficacy safety
Hale clin j Pain 9/99 BACK PaIN
Kaplanr j clin oncol 10/98 CANCER
Stambauugh J Clin Pharm 5/01 CANCer
OxyContin--NDA--1995
MEDICAL OFFICER REVIEW (MOR)
Summary of safety
The best conclusion is that the efficacy
of the Cr(oxycodone) is equivalent to the IR
with an adverse event profile that is as good as
the IR. i would not allow a better'claimi
Curtis Wright, MRO
Oxy Contin---NDA---1995
Summary of efficacy
CR oXycodone appears to be a BId alternative
to conventional QID oxycodone. Approval
recommended. care should be taken to limit
competitive promotion. This product has been
shown to be as good as current therapy but has
not been shown to have a significant advantage
beyond reduction in frequency of dosing
--Curtis Wright. MRO
The Medical Letter--9/17/01
OXyContin is a g 12h controlled-release
formulation of oxycodone that can be used
effectively in the treatment of pain due to
cancer, and occasionally, other types of
chronic pain. There is no evidence that
oxycodone offers any advantage over
appropriate doses of other opioids, and it
appears to have the same potential for
addiction as morphine
CR morphine vS Cr oxycodone
Comparable in
Efficacy and safet
Heiskanen pain 10/97
CANCER
Mucci-LoRusso 98
CANCER
Bruera J. Clin Oncol 10/98 CANCER
IR hydromorphone vs
CR hydromorphone( q12hr
Comparable
Efficacy and Safety
Hayes Cancer 9/94
CANCER
Bruera clin oncol 5/96 CaNCer
CR oXycodone vs Cr hydromorphone
(Q 12hrs)
Comparable
Efficacy safety
Hagen Cancer 4/97
CANCER