Avinza (Morphine Sulfate Extended Release) - Summary

AVINZA SUMMARY

AVINZA^® C II
(morphine sulfate extended-release capsules)
30 mg, 60 mg, 90 mg, 120 mg

R_x Only

AVINZA (morphine sulfate extended-release capsules) 30, 60, 90, and 120 mg contain both immediate release and extended release beads of morphine sulfate for once daily oral administration.

AVINZA capsules are a modified-release formulation of morphine sulfate intended for once daily administration indicated for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time.

AVINZA is NOT intended for use as a prn analgesic.

The safety and efficacy of using AVINZA in the postoperative setting has not been evaluated. AVINZA is not indicated for postoperative use. If the patient has been receiving the drug prior to surgery, resumption of the pre-surgical dose may be appropriate once the patient is able to take the drug by mouth. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (see American Pain Society guidelines)

AVINZA is a mu-agonist opioid and is a Schedule II controlled substance. Morphine, like other opioids used in analgesia, can be abused and is subject to criminal diversion.

AVINZA is intended for oral use only. Abuse of the crushed capsule poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. With parenteral abuse, the capsule excipients, especially talc, can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

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NEWS HIGHLIGHTS

Media Articles Related to Avinza (Morphine Extended Release)

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 Avinza (Morphine Extended Release)

Pharmacokinetics of an immediate and extended release oral morphine formulation utilizing the spheroidal oral drug absorption system in dogs. [2009.04]
This study investigated the pharmacokinetics of a human-labeled oral morphine formulation consisting of both immediate and extended release components in dogs. In a randomized design, 14 dogs were administered either 1 or 2 mg/kg morphine orally... However, the low morphine plasma concentrations and high variability produced from this formulation, suggest that the clinical application of this formulation at the doses evaluated in this study are limited.

Factors affecting dosing regimens of morphine sulfate extended-release (KADIAN) capsules. [2009.01]
Although most extended-release morphine formulations are indicated for use once-daily (q24h) or twice-daily (q12h), KADIAN (morphine sulfate extended-release) capsules, which contain polymer-coated, extended-release morphine sulfate pellets, are indicated for q24h and q12h dosing... Results demonstrate that KADIAN was effective in relieving pain and improving sleep and quality-of-life scores, regardless of whether patients dosed q24h or q12h, and that dosing decisions can be made, based on individual factors, within the first few weeks of therapy.

Single-dose, extended-release epidural morphine (DepoDur) compared to conventional epidural morphine for post-cesarean pain. [2007.07]
BACKGROUND: A single-dose of neuraxial morphine sulfate provides good post-Cesarean analgesia; however, its efficacy is limited to the first postoperative day. In a recent phase III study, extended-release epidural morphine (EREM) formulation provided more effective, prolonged analgesia after Cesarean delivery, compared to conventional epidural morphine. However, the study protocol did not allow for the use of nonsteroidal antiinflammatory drugs, used various postoperative analgesics, and monitoring and treatment of respiratory depression were not standardized. Our aims in this study were to compare postoperative analgesic consumption, pain scores and side effects of EREM with conventional morphine for the management of post-Cesarean pain in a setting more reflective of current obstetric practice... CONCLUSION: EREM provides superior and prolonged post-Cesarean analgesia compared to conventional epidural morphine with no significant increases in adverse events.

A randomized, open-label, multicenter trial comparing once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled-release tablets) for the treatment of chronic, moderate to severe low back pain: improved physical functioning in the ACTION trial. [2007.01]
This multicenter trial compared the efficacy, safety, and effect on quality of life and work limitation of once-daily extended-release morphine sulfate capsules (AVINZA, A-MQD) and twice-daily controlled-release oxycodone HCI tablets (OxyContin, O-ER) in subjects with chronic, moderate to severe low back pain...

A randomized, open-label study of once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled-release tablets) for chronic low back pain: the extension phase of the ACTION trial. [2006.11]
CONCLUSIONS: Both study drugs resulted in significant pain relief and improved sleep in SRO-naive patients with chronic low back pain, and this outcome was attained with a stable daily SRO dose. In patients who completed opioid dose titration, A VINZA performed significantly better than OxyContin in reducing pain scores and improving sleep-with a lower morphine-equivalent daily dose-during both the evaluation and extension phases.

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Clinical Trials Related to Avinza (Morphine Extended Release)

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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