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)

Erectile Dysfunction Tied To Long Term Painkiller Use
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.16]
A new study suggests that long term use of opioid prescription painkillers for back pain is tied to a higher risk of erectile dysfunction (ED). The findings are published in the 15 May online issue of the journal Spine. Lead author Richard A...

Painkillers Increase Risk of Erectile Dysfunction
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.15]
Regularly taking prescription painkillers, commonly called opioids, is linked to a greater risk of erectile dysfunction (ED) in men, according to a new study published in Spine. Over 11,000 men suffering from back pain were involved in the research...

Retooling Pain Assessment for Older Adults
Source: Medscape Emergency Medicine Headlines [2013.05.14]
Current pain assessment tools for older adults are inadequate, and education for healthcare professionals falls short in meeting the unique challenges posed by pain management for elderly patients.
Medscape Medical News

Tanezumab Makes Good in Chronic Back Pain (CME/CE)
Source: MedPage Today Neurology [2013.05.14]
NEW ORLEANS (MedPage Today) -- The controversial agent tanezumab, which was once put on an FDA regulatory hold, offered durable reduction of chronic low back pain, a long-term safety and efficacy study showed.

Persistent Pain After Sexual Assault Often Untreated
Source: Medscape Nurses Headlines [2013.05.13]
Although pain is common after sexual assault, more than 50% of women don't seek appropriate medical care 6 weeks after presenting to the ED.
Medscape Medical News

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Published Studies Related to Avinza (Morphine Extended Release)

Prior epidural lidocaine alters the pharmacokinetics and drug effects of extended-release epidural morphine (DepoDur(R)) after cesarean delivery. [2011.08]
BACKGROUND: A potential physicochemical interaction between epidural local anesthetics and extended-release epidural morphine (EREM) could negate the sustained release. In this study, we sought to determine the pharmacokinetic and drug effects of prior epidural lidocaine administration on EREM... CONCLUSION: A large dose of epidural lidocaine 1 hour before EREM administration alters the pharmacokinetics and drug effects of EREM. Clinicians must apply caution when EREM is administered even 1 hour after an epidural lidocaine "top-up" for cesarean delivery.

Impact of intravenous naltrexone on intravenous morphine-induced high, drug liking, and euphoric effects in experienced, nondependent male opioid users. [2011]
naltrexone in a clinical simulation of intravenous abuse of crushed MS-sNT... CONCLUSIONS: Results in this study population suggest that naltrexone added to

Food effects on the pharmacokinetics of morphine sulfate and naltrexone hydrochloride extended release capsules. [2010.11]
INTRODUCTION: Morphine sulfate and naltrexone hydrochloride extended release capsules, indicated for chronic moderate-to-severe pain, contain extended-release morphine pellets with a sequestered naltrexone core. If pellets are tampered by crushing, naltrexone is released to reduce morphine-induced effects that appeal to opioid abusers. The primary objective of this study was to assess single-dose relative bioavailability of morphine when morphine sulfate and naltrexone hydrochloride extended release capsules were taken under fed and fasting conditions and when pellets were sprinkled on apple sauce... CONCLUSION: Results indicated that morphine sulfate and naltrexone hydrochloride extended release capsules can be administered without regard to meals, and contents can be sprinkled over apple sauce and consumed without chewing by patients with difficulty swallowing.

Morphine sulfate and naltrexone hydrochloride extended release capsules in patients with chronic osteoarthritis pain. [2010.07]
OBJECTIVE: To assess the efficacy and safety of morphine sulfate and naltrexone hydrochloride extended release capsules (EMBEDA; MS-sNT), which contain morphine sulfate pellets with a sequestered naltrexone core, in treating patients with chronic, moderate-to-severe osteoarthritis (hip or knee) pain... CONCLUSION: MS-sNT provided effective analgesia in patients with chronic, moderate-to-severe osteoarthritis pain, with a safety profile typical of morphine-containing products. Naltrexone sequestered in MS-sNT had no clinically relevant effect when MS-sNT was taken as directed.

ALO-01 (morphine sulfate and naltrexone hydrochloride) extended-release capsules in the treatment of chronic pain of osteoarthritis of the hip or knee: pharmacokinetics, efficacy, and safety. [2010.04]
ALO-01 (EMBEDA [morphine sulfate and naltrexone hydrochloride] extended-release capsules [King Pharmaceuticals, Inc, Bridgewater, NJ]), indicated for chronic moderate-to-severe pain, is designed to release naltrexone upon tampering (eg, by crushing), reducing morphine-induced subjective effects.

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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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Reports of Suspected Avinza (Morphine Extended Release) Side Effects

Pain (18),  Multiple Drug Overdose (13),  Vomiting (12),  Anxiety (11),  Drug Ineffective (10),  Substance Abuse (10),  Muscular Weakness (10),  Insomnia (10),  Drug Dependence (10),  Confusional State (9), more >>