DEPODUR SUMMARY
DepoDur® (morphine sulfate extended-release liposome injection) CII Rx Only
DepoDur (morphine sulfate extended-release liposome injection) is a sterile suspension of multivesicular liposomes containing morphine sulfate, intended for epidural administration.
DepoDur (morphine EPIDURAL) is indicated for the following:
DepoDur is an extended-release liposome injection of morphine sulfate intended for single-dose administration by the epidural route, at the lumbar level, for the treatment of pain following major surgery. DepoDur is administered prior to surgery or after clamping the umbilical cord during cesarean section.
DepoDur is not intended for intrathecal, intravenous, or intramuscular administration. Administration of DepoDur into the thoracic epidural space or higher has not been evaluated and therefore is not recommended.
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NEWS HIGHLIGHTSMedia Articles Related to Depodur (Morphine Epidural)
62-Year-Old Man Becomes First Patient In China Implanted With Rechargeable Neurostimulator For Chronic Pain Source: Health News from Medical News Today [2009.11.19] St. Jude Medical, Inc. (NYSE:STJ) announced that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon™ neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.



Common Pain Relief Medication May Encourage Cancer Growth Source: Cancer / Oncology News From Medical News Today [2009.11.19] Although morphine has been the gold-standard treatment for postoperative and chronic cancer pain for two centuries, a growing body of evidence is showing that opiate-based painkillers can stimulate the growth and spread of cancer cells. Two new studies advance that argument and demonstrate how shielding lung cancer cells from opiates reduces cell proliferation, invasion and migration in both cell-culture and mouse models.
CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Francisco Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19] CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr.
Transplanting People's Own Stem Cells Into Heart Lessens Pain, Improves Ability To Walk Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19] The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.
FDA Approves New Drug For Pain That Persists After Shingles Source: Dermatology News From Medical News Today [2009.11.18] The US Food and Drug Administration (FDA) announced yesterday that it has approved Qutenza (capsaicin) 8% patch for the treatment of post-herpetic neuralgia (PHN), an often excruciating pain that can persist for weeks, months and even years in 10 to 15 per cent of people who get shingles. The medicated skin patch, which is made by Lohmann Therapie-Systems AD of Andernach, Germany and distributed in the US by NeurogesX Inc.
Published Studies Related to Depodur (Morphine Epidural)
A comparison of morphine concentrations for patient-controlled epidural analgesia following gynecological surgery. [2009.09] AIM: To compare the analgesic efficacy of a lower (12.5 mg/mL) vs. higher (25 mg/mL) concentration of morphine with 0.2% ropivacaine for patient-controlled epidural analgesia (PCEA) following gynecological surgery... CONCLUSIONS: PCEA using 0.2% ropivacaine and 12.5 mg/mL morphine compared with 0.2% ropivacaine and 25 mg/mL morphine provides equianalgesia with no differences in bolus administration. With respect to the analgesic efficacy and the potential risk for side effects, PCEA using 0.2% ropivacaine and 12.5 mg/ml morphine is a better choice for postoperative gynecological patients.
Midazolam as an antiemetic in patients receiving epidural morphine for postoperative pain relief. [2009.07] PURPOSE: Epidural morphine has been associated with a significant incidence of postoperative nausea and vomiting (PONV). The authors have evaluated the prophylactic effects of midazolam in preventing nausea and vomiting following epidural morphine for postoperative pain control... CONCLUSION: The authors conclude that low-dose midazolam infusion is effective in the prevention of nausea, vomiting, and pruritus following epidural morphine for postoperative pain control.
Subarachnoid morphine, bupivacaine and fentanyl as part of combined spinal-epidural analgesia for low anterior resection. A prospective, randomised, double-blind clinical trial. [2009.07] This study was designed to compare the efficacy of subarachnoid morphine alone or in combination with bupivacaine and fentanyl for combined spinal-epidural analgesia in colorectal surgery... The addition of bupivacaine and fentanyl to subarachnoid morphine did not confer any advantage on postoperative visual analogue scale scores and tramadol use, but lowered the need for additional intraoperative intravenous fentanyl and epidural bupivacaine and prolonged the time to first analgesia request.
The interaction between epidural 2-chloroprocaine and morphine: a randomized controlled trial of the effect of drug administration timing on the efficacy of morphine analgesia. [2009.07] BACKGROUND: The efficacy and duration of epidural morphine analgesia is diminished when administered after 2-chloroprocaine compared with lidocaine. The mechanism of the interaction between 2-chloroprocaine and morphine is unknown... This suggests that the observed interaction between epidural morphine and 2-chloroprocaine is a result of differences in latency and duration of action of the two drugs, or that the administration of morphine before 2-chloroprocaine effectively blocks a receptor site antagonism.
Treatment of ischemic pain in patients suffering from peripheral vasculopathy with transdermal buprenorphine plus epidural morphine with ropivacaine vs. epidural morphine with ropivacaine. [2009.03] Aim: This study compared the efficacy and safety of buprenorphine transdermal delivery system with peridural infusion of morphine and ropivacaine to peridural infusion alone for the control of ischemic pain in patients suffering from peripheral vasculopathy... Conclusion: Transdermal buprenorphine use resulted in significant pain relief with excellent patient satisfaction, which may translate into improvement in mood and quality of life.
Clinical Trials Related to Depodur (Morphine Epidural)
Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction [Completed]
This study involves approximately 200 patients designed to evaluate the efficacy and safety
of intranasal (IN) morphine 7. 5 mg and 15 mg, intravenous morphine (IV) 7. 5 mg, immediate
release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain
following third molar extraction.
Intrathecal Morphine in Knee Arthroplasty [Completed]
This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain
relief and side effect profiles of same in the setting of Total Knee Replacement. We
hypothesized that a dose greater than that used in Total Hip Replacement was needed and
wished to find a dose which was effective but had a low side effect profile.
Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery [Completed]
Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray
(MNS075) 3. 75 mg, 7. 5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7. 5 mg, or IN placebo
in patients with moderate to severe post-surgical pain following orthopedic surgery. After
initial dosing, up to six (6) doses of IN MNS075 7. 5 mg or 15 mg for up to twenty-four (24)
hours will be evaluated. The rescue dose remained the same for each.
A Study of Kadian NT in Subjects With Pain Due to Osteoarthritis of the Hip or Knee [Completed]
The purpose of this study is to evaluate the efficacy of Kadian NT compared with placebo for
treating moderate to severe chronic pain over a 12 week period.
INFUSE Morphine Study [Completed]
Double-blind study comparing the pharmacokinetics, safety and tolerability of morphine
administered subcutaneously (SC) with and without human recombinant hyaluronidase (HYLENEX)
and intravenously conducted in patients in a hospice care setting or through a palliative
care medicine setting. In this within-patient controlled study, each eligible study patient
receives a single injection by each of the three methods of morphine administration,
sequentially on three consecutive days, according to the order specified by a randomization
schedule.
Each of the three injections consists of 5 mg of morphine (1. 0 mL of 5 mg/mL solution). The
HYLENEX injection will be 1 mL of 150 units. Although the IV administration will not be
blinded, the two SC injections will be double-blinded, using the same volume of normal saline
(0. 9% sodium chloride) placebo (1. 0 mL) as HYLENEX.
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