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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AVINZA NEWS HIGHLIGHTS

Media Articles Related to Avinza (Morphine Extended Release)

New Treatment For Receding Gums: No Pain, Lots Of Gain
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2009.07.02]
Tufts dental researchers conducted a three-year follow-up study that examined the stability of a treatment option for receding gums and found that complete root coverage the goal of the surgery had been maintained. This specific tissue regeneration application, developed at Tufts, reduces the considerable pain and recovery time of gum grafting surgery. The case study of six patients is published in the July 2009 issue of the Journal of Periodontology.

Increasing Age Of Mothers In Spain Leads To Rise In Mortality Rates
Source: Seniors / Aging News From Medical News Today [2009.07.02]
A new study examining the evolution of maternal mortality rates in Spain since 1996 shows a 17% increase in deaths. This trend is linked to the widespread increase in maternal age. The highest death rates are among foreign women and those who live in the province of Malaga. Medicine has taken giant strides during the 20th Century. However, European studies show a clear and constant increase in maternal mortality rates over recent years.

Health Tip: What's Causing My Neck Pain?
Source: MedicineNet Arthritis Specialty [2009.07.02]
Title: Health Tip: What's Causing My Neck Pain?
Category: Health News
Created: 7/2/2009 7:00:00 AM
Last Editorial Review: 7/2/2009

Laughter - The Best Medicine? Spain Hosts The Most Renowned International Symposium On Sense Of Humor And Its Applications
Source: Conferences News From Medical News Today [2009.07.01]
Spain hosts this week, for the first time in history, this event, the most renowned international symposium on humour and laughter, where scientists and experts from four continents will discuss the latest advances and research of this field of study.

Lower Empathic Responses To Outsiders' Pain Shown By Imaging Study
Source: Neurology / Neuroscience News From Medical News Today [2009.07.01]
An observer feels more empathy for someone in pain when that person is in the same social group, according to new research in the July 1 issue of The Journal of Neuroscience. The study shows that perceiving others in pain activates a part of the brain associated with empathy and emotion more if the observer and the observed are the same race. The findings may show that unconscious prejudices against outside groups exist at a basic level.

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Published Studies Related to Avinza (Morphine Extended Release)

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... In conclusion, compared to twice-daily OxyContin, once-daily A VINZA resulted in significantly better and earlier improvement ofp hysicalf unction and ability to work.

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.

Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain. [2006.08]
CONCLUSIONS: P-ERMS and CRO both relieved chronic nonmalignant pain in this community-based population; however, patients taking P-ERMS dosed in accordance with FDA-approved frequencies (QD/BID); 44% of those taking CRO dosed more frequently (TID/QID).

Single-dose extended-release epidural morphine for pain after hip arthroplasty. [2006.07]
This randomized, double-blind study compared the safety and efficacy of a new single-dose extended-release epidural morphine (EREM) formulation for postoperative pain following hip arthroplasty. Patients were administered a single dose of EREM (10, 20, or 30 mg, n = 93) or a single epidural dose of placebo (n = 27) before surgery and general anesthesia...

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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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