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In another study with 164 patients undergoing knee replacement surgery, patients 18 years of age or over were randomized to receive either an epidural injection of DepoDur^TM 20 mg, DepoDur^TM 30* mg, or a placebo epidural before or during surgery. At the first request for pain medication after surgery, patients in the DepoDur^TM group were given an IV bolus of hydromorphone and placebo via IV patient-controlled analgesia (PCA). Those patients randomized to the control group (IV PCA group) were given an IV bolus of morphine and morphine via IV PCA for pain relief. Pain intensity recall scores (100-mm Visual Analog Scale [VAS]) were assessed at 4, 8, 12, 24, 30, 36, and 48 hours. The results demonstrated DepoDur^TM to be a safe and effective alternative to IV opioid PCA for postoperative pain, providing effective pain control with less use of supplemental opioids over the 48-hour postoperative period. In the DepoDur^TM group, patient pain intensity ratings were significantly lower than in the IV PCA group.

About DepoDur^TM

Previously referred to as DepoMorphine^TM, DepoDur^TM is the first single-dose extended-release epidural formulation of morphine sulfate approved by the FDA for the treatment of pain following major surgery. DepoDur^TM employs SkyePharma's (LSE: SKP; Nasdaq: SKYE) proprietary DepoFoam^TM technology and is supplied as a ready-to-use suspension. DepoDur^TM is intended for single-dose administration by the epidural route, at the lumbar level, for the treatment of pain following major surgery. DepoDur^TM is administered prior to surgery or after clamping the umbilical cord during cesarean section. DepoDur^TM is not intended for intrathecal, intravenous, or intramuscular administration. Administration of Depo
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Contact: Wendy Lu
wendy_lu@nyc.cohnwolfe.com
212-798-9839
Cohn & Wolfe
26-Oct-2004