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Nucynta (Tapentadol Hydrochloride) - Summary

 
 



NUCYNTA SUMMARY

NUCYNTA™ (tapentadol) Tablets are immediate-release film-coated tablets for oral administration.

NUCYNTA™ (tapentadol) is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.


See all Nucynta indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Nucynta (Tapentadol)

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 Nucynta (Tapentadol)

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.

Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial. [2011.01]
CONCLUSIONS: Compared with placebo, tapentadol ER 100-250 mg bid provided a statistically significant difference in the maintenance of a clinically important improvement in pain 1 , 2 and was well-tolerated by patients with painful DPN.

Post hoc analyses of data from a 90-day clinical trial evaluating the tolerability and efficacy of tapentadol immediate release and oxycodone immediate release for the relief of moderate to severe pain in elderly and nonelderly patients. [2011]
and nonelderly patients... CONCLUSIONS: Tapentadol IR was safe and effective for the relief of lower back

Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial. [2010.12.02]
Abstract Objective: Painful diabetic peripheral neuropathy (DPN) may not be adequately managed with available therapeutic options. This phase III, randomized-withdrawal, placebo-controlled trial evaluated the safety and efficacy of tapentadol extended release (ER) for relieving painful DPN... Conclusions: Compared with placebo, tapentadol ER 100-250 mg bid provided a statistically significant difference in the maintenance of a clinically important improvement in pain 1 , 2 and was well-tolerated by patients with painful DPN.

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Clinical Trials Related to Nucynta (Tapentadol)

Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin [Recruiting]
The main objective of the study is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol prolonged release (PR) (500 mg per day) versus a combination of tapentadol PR (300 mg per day) and pregabalin (to 300 mg per day) in subjects requiring additional analgesia after titration to tapentadol PR 300 mg per day.

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 outcomes. Since, severe low back pain with a neuropathic component, the targeted study population, is frequently treated with a combination therapy (monotherapy is often not effective enough) it is of interest to determine if tapentadol alone (combining 2 mechanisms of action in a single molecule) could be as effective as a combination of tapentadol plus pregabalin. Furthermore, the tolerability profiles of monotherapy versus combination are of interest.

NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain [Recruiting]
Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.

A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy [Recruiting]
The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR 50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours (SPID48) to measure analgesic effect in Korean patients with acute pain following bunionectomy.

A Safety and Effectiveness Study of Prolonged Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Chronic Non-Cancer Pain [Not yet recruiting]

A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain [Not yet recruiting]

more trials >>

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 >>


Page last updated: 2013-05-16

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