Numorphan (Oxymorphone Hydrochloride) - Summary

NUMORPHAN SUMMARY

NUMORPHAN^®
(Oxymorphone Hydrochloride Injection, USP) CII
(Oxymorphone Hydrochloride Suppositories, USP)
Opioid
Analgesic

Rx only

NUMORPHAN (oxymorphone hydrochloride, USP), a semi-synthetic opioid substitute for morphine, is a potent analgesic.

NUMORPHAN Suppository is indicated for the relief of moderate to severe pain.

NUMORPHAN Injection is indicated for the relief of moderate to severe pain. It is also indicated for preoperative medication, for support of anesthesia, for obstetrical analgesia, and for relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular dysfunction.

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NEWS HIGHLIGHTS

Media Articles Related to Numorphan (Oxymorphone)

Yoga May Be Effective For Chronic Low Back Pain In Minority Populations
Source: Health News from Medical News Today [2009.11.05]
Researchers from Boston University School of Medicine (BUSM) and Boston Medical Center found that yoga may be more effective than standard treatment for reducing chronic low back pain in minority populations. This study appears in the November issue of Alternative Therapies in Health and Medicine.

Radiation Therapy Technique Successfully Treats Pain In Patients With Advanced Cancer
Source: Cancer / Oncology News From Medical News Today [2009.11.05]
Stereotactic radiosurgery (SRS), a radiation therapy procedure pioneered at the University of Pittsburgh Cancer Institute (UPCI) that precisely delivers a large dose of radiation to tumors, effectively controls pain in patients with cancer that has spread to the spine, according to researchers from UPCI. The results of the research were presented this week during the American Society for Radiation Oncology (ASTRO) annual meeting in Chicago, being held November 1 - 5, 2009.

Common Pain Relievers May Dilute Power Of Flu Shots
Source: Biology / Biochemistry News From Medical News Today [2009.11.04]
With flu vaccination season in full swing, research from the University of Rochester Medical Center cautions that use of many common pain killers -- Advil, Tylenol, aspirin -- at the time of injection may blunt the effect of the shot and have a negative effect on the immune system. Richard P. Phipps, Ph.D.

Cancer, Pain Relief And Immunity Research Supported By ARC
Source: Breast Cancer News From Medical News Today [2009.11.04]
Research at the Walter and Eliza Hall Institute into the genes involved in breast cancer development, new drugs for chronic pain, and the proteins involved in inflammatory diseases has received funding in this year's round of Australian Research Council (ARC) Discovery Project grants. Seven projects proposed by institute researchers have received ARC support.

From A Neuroscience Of Pain To A Neuroethics Of Care
Source: Neurology / Neuroscience News From Medical News Today [2009.11.04]
Science now offers us ever more advanced ways to understand and control pain. But with those new treatments come new questions about the use (and misuse) of state-of-the-art technology and how far pain management can and should go.

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Published Studies Related to Numorphan (Oxymorphone)

The pain quality response profile of oxymorphone extended release in the treatment of low back pain. [2009.02]
OBJECTIVE: In controlled trials of analgesics, the primary outcome variable is most often a measure of global pain intensity. However, because pain is associated with a variety of pain sensations, the effects of analgesic treatments on different sensations could go undetected if specific pain qualities are not assessed...

Oxymorphone extended release for the treatment of chronic low back pain: a retrospective pooled analysis of enriched-enrollment clinical trial data stratified according to age, sex, and prior opioid use. [2009.02]
OBJECTIVE: This study assessed the potential effects of age, sex, and prior opioid use on the response to oxymorphone extended release (ER) in patients with moderate to severe chronic low back pain... CONCLUSION: In the enriched population of patients who successfully titrated to oxymorphone ER, oxymorphone ER was effective and generally well tolerated, independent of patients' age, sex, or previous opioid use.

Comparison of the analgesic efficacy of hydromorphone and oxymorphone in dogs and cats: a randomized blinded study. [2008.07]
OBJECTIVE: To determine if oxymorphone and hydromorphone are equally efficacious as analgesics in both dogs and cats and to determine the side-effects of each drug in painful animals...

Efficacy and tolerability of oxymorphone immediate release for acute postoperative pain after abdominal surgery: a randomized, double-blind, active- and placebo-controlled, parallel-group trial. [2007.06]
BACKGROUND: Patients are typically switched from parenteral opioids to oral opioids during the 24 to 48 hours after surgery. In June 2006, an oral immediate-release (IR) tablet formulation of oxymorphone was approved for the treatment of acute moderate to severe pain. Single doses of oxymorphone IR have been reported to provide significant pain relief after orthopedic surgery. OBJECTIVE: This study assessed the efficacy and tolerability of multiple fixed doses of oxymorphone IR in the treatment of acute postoperative pain after abdominal surgery... CONCLUSION: In this predominantly female population undergoing abdominal surgery, oxymorphone IR given every 4 to 6 hours for up to 48 hours provided efficacious and tolerable analgesia for moderate to severe pain.

Efficacy and Safety of OPANA ER (Oxymorphone Extended Release) for Relief of Moderate to Severe Chronic Low Back Pain in Opioid-Experienced Patients: A 12-Week, Randomized, Double-blind, Placebo-controlled Study. [2007.02]
Opioid-experienced (N = 250) patients with chronic, moderate to severe low back pain (LBP) were converted from their prestudy opioid(s) to an approximately equianalgesic dose of OPANA ER (oxymorphone extended release). Patients continued slow titration, with 56% stabilized within 1 month to a dose of OPANA ER that reduced average pain to <40 mm on a visual analog scale with good tolerability...

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Clinical Trials Related to Numorphan (Oxymorphone)

Effect of Extended-Release Oxymorphone Taking With or Without Food on Cognitive Functioning [Recruiting]
The purpose of the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under conditions of fasting.

A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone [Recruiting]
This project will explore the safety and feasibility of performing a successful intravenous patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral ER Oxymorphone (extended release or OPANA ER) in the outpatient setting.

A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation) [Recruiting]
he purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the swithcing from one pain medication to another can be done over a 24 hour period. Oxymorhone, the drug being studied, is an FDA approved drug for treatment of severe pain.

Efficacy and Safety of Oxymorphone Immediate Release in Post-Surgical Acute Pain [Completed]
The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.

Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain [Completed]
The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in opioid-experienced patients with chronic low back pain.

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