PRODUCT: DEPODUR
PARTNER: ENDO (U.S.)/ZENEUS PHARMA (Europe)
There is widespread recognition that relief of post-operative pain is sub-optimal. In
DepoDur (previously known as DepoMorphine), our DepoFoam sustained-release injectable
technology maintains therapeutically effective levels of morphine for 48 hours (the period of
peak post-operative pain) from a single epidural injection given before or during the
procedure. Epidural analgesia has many theoretical advantages but is only used in about
50% of procedures today because of some practical issues. Conventional morphine is relatively
short-acting so the epidural catheter has to be left in place. This impairs patient mobility
and may cause complications such as infections and bleeding within the spinal column that could
cause paralysis. DepoDur eliminates the need for an indwelling catheter and infusion pumps.
Clinical trials in several different post-operative indications confirm that the product is safe and
at least as effective as conventional morphine. DepoDur was filed with the FDA in July 2003, approved
in May 2004 and launched in the USA in December 2004. DepoDur was filed in Europe in November 2003
and was approved by the MHRA in April 2006. DepoDur was licensed to Endo Pharmaceuticals for
North America at the end of 2002 and to Zeneus Pharma for Europe in 2004 . However following
the 2005 acquisition of Zeneus by Cephalon SkyePharma has reacquired the rights in Europe.
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"Postoperative pain management continues to be a significantly
underserved area. DepoMorphine holds the
promise of providing excellent pain relief without the burdens and risk
associated with indwelling catheters. Anyone having a major operation will
appreciate this advantage."
Thomas Jefferson University - Eugene Viscusi, MD, Director, Acute Pain
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"DepoMorphine will substantially improve
treatment of post-operative pain... DepoMorphine
offers us the ability to give 2 to 3 days of highly reliable and effective pain
relief in a much higher percentage of our patients."
Stanford University - Edward Riley MD, Associate Professor |
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"DepoMorphine may prove to be a revolutionary
drug in postoperative pain management. The pain relief provided by DepoMorphine
is far superior to that which can be achieved by PCA...up to at least 48
hours... The lack of need for catheter infusions may
simplify pain management...especially in orthopedic patients where this may
allow superior rehabilitation of patients."
Duke University - Gavin Martin, MD, Assistant Clinical Professor |
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For further information on DepoDur, please visit
www.depodur.com or email
SkyePharma at ir@skyepharma.co.uk.