Duramorph (Morphine Sulfate Epidural) - Summary

DURAMORPH SUMMARY

DURAMORPH (morphine sulfate injection, USP)
PRESERVATIVE-FREE
CII
Rx only

Morphine is the most important alkaloid of opium and is a phenanthrene derivative.

Duramorph (Morphine EPIDURAL) is indicated for the following:

DURAMORPH is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain not responsive to non-narcotic analgesics. DURAMORPH administered epidurally or intrathecally, provides pain relief for extended periods without attendant loss of motor, sensory or sympathetic function.

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NEWS HIGHLIGHTS

Media Articles Related to Duramorph (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.

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Published Studies Related to Duramorph (Morphine Epidural)

Efficacy of a low-dose spinal morphine with bupivacaine for postoperative analgesia in children undergoing hypospadias repair. [2009.11]
BACKGROUND: Children undergoing hypospadias repair need to be protected from highly unpleasant sensory and emotional experiences during and after surgery. We designed a double-blinded, randomized, and placebo-controlled study to compare the efficacy of a low-dose (2 microg x kg(-1)) of intrathecal morphine with placebo for postoperative pain control of children undergoing repair of hypospadias surgery with spinal anesthesia... CONCLUSION: Spinal anesthesia provided by hyperbaric bupivacaine is adequate for distal hypospadias repair in children, but adding 2 microg x kg(-1) intrathecal morphine provides better postoperative pain control when compared to placebo in these children.

A comparison of intravenous oxycodone and intravenous morphine in patient-controlled postoperative analgesia after laparoscopic hysterectomy. [2009.10]
INTRODUCTION: In this study, we investigated the dose requirements, pain relief, and side effects of oxycodone versus morphine after surgery with visceral pain... CONCLUSIONS: Oxycodone was more potent than morphine for visceral pain relief but not for sedation.

Intravenous paracetamol or morphine for the treatment of renal colic: a randomized, placebo-controlled trial. [2009.10]
STUDY OBJECTIVE: This randomized, placebo-controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol and morphine for the treatment of renal colic... CONCLUSION: Intravenous paracetamol is an efficacious and safe treatment for ED patients with renal colic.

Prevalence of Delirium with Dexmedetomidine Compared with Morphine Based Therapy after Cardiac Surgery: A Randomized Controlled Trial (DEXmedetomidine COmpared to Morphine-DEXCOM Study). [2009.09.25]
BACKGROUND:: Commonly used sedatives/analgesics can increase the risk of postoperative complications, including delirium. This double-blinded study assessed the neurobehavioral, hemodynamic, and sedative characteristics of dexmedetomidine compared with morphine-based regimen after cardiac surgery at equivalent levels of sedation and analgesia... CONCLUSION:: Dexmedetomidine reduced the duration but not the incidence of delirium after cardiac surgery with effective analgesia/sedation, less hypotension, less vasopressor requirement, and more bradycardia versus morphine regimen.

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.

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Clinical Trials Related to Duramorph (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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