NUCYNTA SUMMARY
NUCYNTA® (tapentadol) is a mu-opioid receptor agonist, supplied in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 75, and 100 mg of tapentadol free-base, respectively.
NUCYNTA® (tapentadol) is indicated for the management of moderate to severe acute pain in adults.
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NEWS HIGHLIGHTSMedia Articles Related to Nucynta (Tapentadol)
The Opioid Crisis and Need for Compassion in Pain Management Source: Medscape Anesthesiology Headlines [2017.09.28] In this commentary, the author expresses concern that the response to the public health crisis of opioid addiction is creating a growing crisis of inadequate pain management. American Journal of Public Health
CVS to Restrict Opioid Painkiller Prescription Amounts Source: MedicineNet Drug Abuse Specialty [2017.09.25] Title: CVS to Restrict Opioid Painkiller Prescription Amounts Category: Health News Created: 9/22/2017 12:00:00 AM Last Editorial Review: 9/25/2017 12:00:00 AM
Stomach Pain Quiz: Nausea & Other Causes Source: MedicineNet Anal Fissure Specialty [2017.09.19] Title: Stomach Pain Quiz: Nausea & Other Causes Category: MedicineNet Quiz Created: 1/20/2011 12:00:00 AM Last Editorial Review: 9/19/2017 5:59:56 PM
Back Pain Quiz: Test Your Back Pain IQ Source: MedicineNet Ankylosing Spondylitis Specialty [2017.09.19] Title: Back Pain Quiz: Test Your Back Pain IQ Category: MedicineNet Quiz Created: 6/16/2011 3:41:00 PM Last Editorial Review: 9/19/2017 6:39:04 PM
Pain Quiz: Test Your IQ of Pain Source: MedicineNet Constipation Specialty [2017.09.19] Title: Pain Quiz: Test Your IQ of Pain Category: MedicineNet Quiz Created: 7/14/2011 3:53:00 PM Last Editorial Review: 9/19/2017 6:41:41 PM
Published Studies Related to Nucynta (Tapentadol)
Tapentadol potentiates descending pain inhibition in chronic pain patients with
diabetic polyneuropathy. [2014] decrease in noxious heat stimulation)... CONCLUSIONS: Tapentadol's analgesic effect in chronic pain patients with DPN is
Evaluation of blood pressure and heart rate in patients with hypertension who
received tapentadol extended release for chronic pain: a post hoc, pooled data
analysis. [2014] patients with hypertension... CONCLUSION: No clinically meaningful mean changes in heart rate or blood pressure
Bowel function after tapentadol and oxycodone immediate release (IR) treatment in
patients with low back or osteoarthritis pain. [2013] OBJECTIVES: Constipation is a common side effect of opioid therapy. Tapentadol
immediate release (IR) was better tolerated than oxycodone IR in 2 clinical
trials involving patients with low back or osteoarthritis pain... DISCUSSION: Patient-reported bowel function associated with tapentadol IR
treatment was similar to that associated with placebo (10-d trial) and
significantly better than that associated with oxycodone IR treatment (10- and
90-d trials).
Effect of tapentadol extended release on productivity: results from an analysis
combining evidence from multiple sources. [2012] OBJECTIVE: To compare the effects of tapentadol-extended release versus
oxycodone-controlled release for pain relief on productivity by combining
evidence from different sources.
Comparable efficacy and superior gastrointestinal tolerability (nausea, vomiting, constipation) of tapentadol compared with oxycodone hydrochloride. [2011.05] INTRODUCTION: Two randomized, double-blind, placebo-controlled studies in acute and chronic pain treatment, powered to assess noninferiority of the efficacy of tapentadol immediate release (IR) (50 mg, 75 mg) versus oxycodone hydrochloride (HCl) IR (10 mg), established comparable efficacy of tapentadol IR with oxycodone HCl IR, and suggested tapentadol IR's improved gastrointestinal tolerability. The impact of these equianalgesic doses of tapentadol and oxycodone HCl on bowel function and gastrointestinal tolerability was then directly assessed in the current study, using a validated bowel function diary to comprehensively assess opioid-induced constipation symptoms and outcomes... CONCLUSION: Tapentadol IR (50 mg, 75 mg) consistently demonstrated superior gastrointestinal tolerability, including for the most commonly reported events, such as nausea, vomiting, and constipation at doses that provide comparable efficacy with oxycodone HCl IR 10 mg. These findings validate and extend the tolerability findings of the two earlier studies that established comparable efficacy of these tapentadol and oxycodone HCl doses.
Clinical Trials Related to Nucynta (Tapentadol)
NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain [Completed]
Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the
treatment of acute low back pain.
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics [Completed]
The main objective of the study is to evaluate the effectiveness, tolerability, and safety
of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low
back pain (LBP) who are taking either WHO Step I or Step II analgesics or no regular
analgesics. This is a clinical effectiveness trial designed to establish a link between
anticipated clinical outcomes and the clinical practice by means of selected measures of
clinical and subject-reported outcome.
The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I
or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride
prolonged release (PR) treatment during defined periods of evaluation.
A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine [Completed]
The purpose of this study will be to determine whether tapentadol (CG5503) is effective and
safe in the treatment of chronic tumor related pain compared to placebo. In addition
tapentadol (CG5503) will also be compared to morphine controlled release, also referred to
as slow release (SR).
*Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to
as extended release (ER) in the United States.
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking WHO Step III Analgesics But Showing a Lack of Tolerability. [Terminated]
The main objective of the study is to evaluate the effectiveness, tolerability, and safety
of tapentadol hydrochloride prolonged release (PR) in participants suffering from severe
chronic pain due to osteoarthritis of the knee who are taking WHO Step III analgesics and
show lack of tolerability. This is a clinical effectiveness trial designed to establish a
link between anticipated clinical outcomes and the clinical practice by means of selected
measures of clinical and subject-reported outcome. The trial will compare the effectiveness
of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride PR
treatment during defined periods of evaluation.
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability [Terminated]
The main objective of the study is to evaluate the effectiveness, tolerability, and safety
of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low
back pain (LBP) who are taking WHO Step III analgesics and show lack of tolerability. This
is a clinical effectiveness trial designed to establish a link between anticipated clinical
outcomes and the clinical practice by means of selected measures of clinical and
subject-reported outcome.
The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with
that of tapentadol hydrochloride prolonged release treatment during defined periods of
evaluation.
Reports of Suspected Nucynta (Tapentadol) Side Effects
Hallucination (21),
Drug Ineffective (20),
Dizziness (20),
Dyspnoea (20),
Nausea (19),
Confusional State (17),
Feeling Abnormal (17),
Depression (16),
Withdrawal Syndrome (16),
Anxiety (14), more >>
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