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1. Nucynta - tapentadol hydrochloride - pain, severe

Nucynta - tapentadol hydrochloride - pain, severe Tapentadol Hydrochloride | CADTH.ca Find the information you need Tapentadol Hydrochloride Tapentadol Hydrochloride Last Updated: November 27, 2018 Result type: Reports Project Number: SR0563-000 Product Line: Generic Name: tapentadol hydrochloride Brand Name: Nucynta Manufacturer: Paladin Labs Inc. Indications: pain, severe Manufacturer Requested Reimbursement Criteria 1 : For the management of pain severe enough to require daily, continuous

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

2. Quantifying the Exposure of Tapentadol Extended Release in Japanese Patients with Cancer Pain and Bridging Tapentadol Pharmacokinetics Across Populations Using a Modeling Approach.

Quantifying the Exposure of Tapentadol Extended Release in Japanese Patients with Cancer Pain and Bridging Tapentadol Pharmacokinetics Across Populations Using a Modeling Approach. Tapentadol extended release (ER) is approved for the management of chronic and acute pain in adults. There has been no report of tapentadol ER pharmacokinetics in subjects with cancer pain. This analysis investigated tapentadol ER pharmacokinetics in Japanese patients with cancer pain and bridged (...) it with the pharmacokinetics in Japanese healthy subjects and Caucasian patients with cancer pain.Nonlinear mixed-effect pharmacokinetic modeling was conducted based on pooled tapentadol ER concentration data collected in five Phase 1 studies from 138 Japanese and Korean healthy subjects and in two Phase 3 studies from 215 Japanese and Korean subjects with cancer pain. Expected tapentadol exposure in subjects with different characteristics was assessed via simulation. Tapentadol ER exposures in Caucasian populations were

2017 Clinical drug investigation

3. Oral tapentadol for cancer pain. (PubMed)

Oral tapentadol for cancer pain. A large proportion of people with advanced cancer will experience moderate to severe pain. Tapentadol is a novel, centrally acting analgesic medicine acting at the μ-opioid receptor and inhibiting noradrenaline reuptake. The efficacy of tapentadol is stated to be comparable to morphine and oxycodone.To assess the analgesic efficacy of tapentadol for the relief of cancer pain in adults, and the adverse events associated with its use in clinical trials.We searched (...) the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE from January 2005 to July 2015, together with reference lists of retrieved papers and review articles, and two clinical trial registries. Searches started from 2005 because this covered the period during which clinical trials were conducted. We contacted the manufacturer of tapentadol in the UK to find additional trials not identified by electronic searches. We did not restrict searches by language.We included randomised

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2015 Cochrane

4. Tapentadol for chronic musculoskeletal pain in adults. (PubMed)

Tapentadol for chronic musculoskeletal pain in adults. Chronic musculoskeletal pain is a prevalent condition and a major cause of disability and absence from the workplace worldwide. Opioids are frequently used to treat chronic pain, although adverse effects often restrict their long-term benefits. Tapentadol is an opioid and norepinephrine re-uptake inhibitor, which may cause a lower incidence (and severity) of adverse effects compared to other strong opioids.To determine the efficacy, safety (...) and tolerability of tapentadol extended release for moderate-to-severe pain for at least three months for any musculoskeletal cause.We searched electronic databases (CENTRAL, MEDLINE, EMBASE, Web of Science) to March 2014, unrestricted by language, as well as trials registers and reference lists from retrieved studies. We contacted drug manufacturers for further information.Randomised controlled trials (RCTs) of tapentadol in people with chronic musculoskeletal pain, compared to placebo or active control.Two

2015 Cochrane

5. Tapentadol: no therapeutic advance for acute or chronic pain

Tapentadol: no therapeutic advance for acute or chronic pain Prescrire IN ENGLISH - Spotlight ''Tapentadol: no therapeutic advance for acute or chronic pain'', 1 May 2014 {1} {1} {1} | | > > > Tapentadol: no therapeutic advance for acute or chronic pain Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |   |   |   |  Spotlight Tapentadol: no therapeutic advance for acute (...) or chronic pain FEATURED REVIEW Tapentadol is an opioid similar to tramadol. For patients with acute or chronic pain, its analgesic efficacy is unknown, due to the lack of high-quality evaluation, but it provokes the adverse effects common to all opioids. It is better to continue relying on better-established opioids. Full review (4 pages) available for download by subscribers. Abstract The standard opioids for relieving moderate to severe pain are: codeine as a step 2 analgesic and morphine for step 3

2014 Prescrire

6. A combination pharmacotherapy of tapentadol and pregabalin to tackle centrally driven Osteoarthritis pain. (PubMed)

A combination pharmacotherapy of tapentadol and pregabalin to tackle centrally driven Osteoarthritis pain. Many Osteoarthritis (OA) patients report with clinical features to their pain that cannot be explained by purely peripheral mechanisms. Yet, the analgesic agents available that tackle centrally driven chronic pain often provide only partial pain relief, or have dose-limiting side effects. We explored a combination therapy of the centrally acting analgesic agents tapentadol and pregabalin (...) , to investigate if they could be used in combination to provide superior analgesia.Using electrophysiological single-unit recordings taken from spinal wide dynamic range (WDR) neurons, Diffuse Noxious Inhibitory Controls (DNIC) were assessed as a marker of potential changes in descending controls in a monoiodoacetate (MIA) model of OA. We investigated if a subcutaneous injection of tapentadol or pregabalin, both alone and in combination, inhibited neuronal responses and restored the expression of DNIC

2019 European Journal of Pain

7. Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines

Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines - GOV.UK GOV.UK uses cookies to make the site simpler. Search Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines Tapentadol may increase seizure risk in patients taking other medicines that lower seizure (...) threshold, for example, antidepressants and antipsychotics. Serotonin syndrome has also been reported when tapentadol is used in combination with serotoninergic antidepressants. Published 9 January 2019 Last updated 9 January 2019 — From: Therapeutic area: , , , Contents Advice for healthcare professionals: as for all opioid medicines, tapentadol can induce seizures tapentadol should be prescribed with care in patients with a history of seizure disorders or epilepsy tapentadol may increase seizure risk

2019 MHRA Drug Safety Update

8. Cornea nerve fibre state determines analgesic response to tapentadol in fibromyalgia patients without effective endogenous pain modulation. (PubMed)

Cornea nerve fibre state determines analgesic response to tapentadol in fibromyalgia patients without effective endogenous pain modulation. Tapentadol is a centrally acting analgesic with μ-agonistic activity combined with noradrenaline reuptake inhibition. Its mechanism of action relies on improvement of descending pain inhibition. In the current study, tapentadol's ability to enhance conditioned pain modulation (CPM, an experimental measure of descending pain inhibition) was evaluated (...) in fibromyalgia patients with absent or reduced CPM responses.A total of 34 fibromyalgia patients completed this double-blind trial. Patients were randomized to receive treatment with tapentadol sustained-release or placebo for a 3-month period with 1-month follow-up. At baseline, the cornea nerve fibre state (CNFS) was quantified to determine the presence of nerve fibre pathology and assess its value in the prediction of the analgesic response.Tapentadol significantly increased CPM responses during treatment

2019 European Journal of Pain

9. Cost-effectiveness of tapentadol in severe chronic pain in Spain: a cost analysis of data from RCTs

Cost-effectiveness of tapentadol in severe chronic pain in Spain: a cost analysis of data from RCTs Cost-effectiveness of tapentadol in severe chronic pain in Spain: a cost analysis of data from RCTs Cost-effectiveness of tapentadol in severe chronic pain in Spain: a cost analysis of data from RCTs Obradovic M, Ikenberg R, Hertel N, Antonanzas F, Galvez R, Liedgens H Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each (...) abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study examined the cost-effectiveness of tapentadol, compared with opioids that were commonly used, as a first treatment for severe, chronic, non-malignant pain. The authors concluded that tapentadol was likely to be the best initial treatment for severe chronic non-malignant pain, in Spain. All the model

2013 NHS Economic Evaluation Database.

10. Direct conversion from tramadol to tapentadol prolonged release for moderate to severe, chronic malignant tumour-related pain. (PubMed)

Direct conversion from tramadol to tapentadol prolonged release for moderate to severe, chronic malignant tumour-related pain. A recent randomized-withdrawal, active- and placebo-controlled, double-blind phase 3 study showed that tapentadol prolonged release (PR) was effective and well tolerated for managing moderate to severe, chronic malignant tumour-related pain in patients who were opioid naive or dissatisfied with current treatment (Pain Physician, 2014, 17, 329-343). This post hoc (...) , subgroup analysis evaluated the efficacy and tolerability of tapentadol PR in patients who previously received and were dissatisfied with tramadol for any reason and who had a pain intensity ≥5 (11-point numerical rating scale) before converting directly to tapentadol PR.In the original study, eligible patients had been randomized (2:1) and titrated to their optimal dose of tapentadol PR (100-250 mg bid) or morphine sulphate-controlled release (40-100 mg bid) over 2 weeks. The present report focuses

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2018 European journal of pain (London, England)

11. Pharmacokinetics and pharmacodynamics after oral administration of tapentadol hydrochloride in dogs. (PubMed)

Pharmacokinetics and pharmacodynamics after oral administration of tapentadol hydrochloride in dogs. OBJECTIVE To evaluate pharmacokinetic and pharmacodynamic characteristics of 3 doses of tapentadol hydrochloride orally administered in dogs. ANIMALS 6 healthy adult mixed-breed dogs. PROCEDURES In a prospective, randomized crossover study, dogs were assigned to receive each of 3 doses of tapentadol (10, 20, and 30 mg/kg, PO); there was a 1-week washout period between subsequent administrations (...) . Plasma concentrations and physiologic variables were measured for 24 hours. Samples were analyzed by use of high-performance liquid chromatography-tandem mass spectrometry. RESULTS Tapentadol was rapidly absorbed after oral administration. Mean maximum plasma concentrations after 10, 20, and 30 mg/kg were 10.2, 19.7, and 31 ng/mL, respectively. Geometric mean plasma half-life of the terminal phase after tapentadol administration at 10, 20, and 30 mg/kg was 3.5 hours (range, 2.7 to 4.5 hours), 3.7

2018 American journal of veterinary research

12. Patient-relevant outcomes and health-related quality of life in patients with chronic, severe, noncancer pain treated with tapentadol prolonged release-Using criteria of health technology assessment. (PubMed)

Patient-relevant outcomes and health-related quality of life in patients with chronic, severe, noncancer pain treated with tapentadol prolonged release-Using criteria of health technology assessment. To perform a systematic comparison of tapentadol prolonged release (PR) and oxycodone controlled release (CR) using patient-relevant endpoints of efficacy, safety, and health-related quality of life (HRQoL) according to criteria used in health technology assessment. To derive a minimal important (...) difference (MID) for the EQ-5D from three pivotal trials to measure patient-relevant changes in HRQoL.Randomized, double-blind, placebo and active controlled.Outpatient primary care.Patients with severe chronic osteoarthritis pain (two pivotal studies) and severe lower-back pain (one pivotal study) were enrolled. The intent-to-treat population of the three studies comprised a total of 2,968 patients (tapentadol PR arms: 978, oxycodone CR arms: 999, and in the placebo arms: 991).Tapentadol PR (100-250 mg

2018 Journal of opioid management

13. Comparative pharmacology and toxicology of tramadol and tapentadol. (PubMed)

Comparative pharmacology and toxicology of tramadol and tapentadol. Moderate-to-severe pain represents a heavy burden in patients' quality of life, and ultimately in the society and in healthcare costs. The aim of this review was to summarize data on tramadol and tapentadol adverse effects, toxicity, potential advantages and limitations according to the context of clinical use. We compared data on the pharmacological and toxicological profiles of tramadol and tapentadol, after an extensive (...) literature search in the US National Library of Medicine (PubMed). Tramadol is a prodrug that acts through noradrenaline and serotonin reuptake inhibition, with a weak opioid component added by its metabolite O-desmethyltramadol. Tapentadol does not require metabolic activation and acts mainly through noradrenaline reuptake inhibition and has a strong opioid activity. Such features confer tapentadol potential advantages, namely lower serotonergic, dependence and abuse potential, more linear

2018 European Journal of Pain

14. A randomised controlled trial comparing tapentadol with oxycodone in non-breastfeeding women post elective caesarean section. (PubMed)

A randomised controlled trial comparing tapentadol with oxycodone in non-breastfeeding women post elective caesarean section. Tapentadol may allow greater pain relief with reduced 'opioid load' compared to oxycodone. Its use has not been studied in the obstetric population. The objective of this study was to compare the efficacy and side effect profile of tapentadol with oxycodone in patients who received spinal anaesthesia for elective caesarean section. The trial was registered with EU (...) Clinical Trials Register with CT number 2016-001621-33.This was a multicentre, randomised controlled trial. Randomised patients (n = 68) received either 50 mg tapentadol or oxycodone 10 mg 12 hourly postoperatively. The primary endpoint was the sum of pain intensity difference over the first 48 hours of treatment (SPID48). Secondary outcomes included time to rescue medications, SPID36, total pain relief scores (TOTPAR), patient satisfaction scores, sum of total pain relief and pain intensity difference

2018 Current medical research and opinion

15. Opioid use and harms associated with a sustained-release tapentadol formulation: a postmarketing study protocol. (PubMed)

Opioid use and harms associated with a sustained-release tapentadol formulation: a postmarketing study protocol. It has been argued that tapentadol may pharmacologically have lower abuse potential than other pharmaceutical opioids currently available. However, there has been no comprehensive triangulation of data regarding use and harms associated with this formulation. A sustained-release formulation (SRF) of tapentadol (Palexia) was released in Australia in 2011 and listed for public subsidy (...) in 2013. We summarise here the methods of a postmarketing study which will measure postintroduction: (1) population level availability, (2) extramedical use and diversion, (3) attractiveness for extramedical use and (4) associated harms, of tapentadol compared against other pharmaceutical opioids.We evaluated key sources on pharmaceutical use and harms in Australia. This review indicateddata from four sources that disaggregate pharmaceutical opioid formulations and capture tapentadol SRF could

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2018 BMJ open

16. Serotonin Syndrome in Tapentadol Literature: Systematic Review of Original Research.

Serotonin Syndrome in Tapentadol Literature: Systematic Review of Original Research. The potential association between serotonin syndrome and tapentadol is not well described in the literature. This study aimed to review the literature and identify methodological issues that could lead to inaccurately reported rates of serotonin syndrome associated with tapentadol use. A systematic review of English articles using MEDLINE, Cochrane Controlled Trials Register, and Scopus was performed (...) . Additional studies were identified by cross-referencing article bibliographies. Original research that examined the safety of tapentadol in patients with nonconfounding indications were examined. In total, 22 studies met inclusion criteria. There were 13 randomized clinical trials, 7 open-label trials, and 2 observational studies. All studies either did not mention whether serotonergic medication use was prohibited or disallowed use. Frequently reported adverse events were nausea, diarrhea, constipation

2018 Journal of pain & palliative care pharmacotherapy

17. Tapentadol Extended Release in the Treatment of Severe Chronic Low Back Pain and Osteoarthritis Pain (PubMed)

Tapentadol Extended Release in the Treatment of Severe Chronic Low Back Pain and Osteoarthritis Pain Tapentadol is a novel pain reliever with apparently synergistic dual mechanisms of action, capable of addressing both nociceptive and neuropathic components of chronic pain. As an effective analgesic with good tolerability, tapentadol may be appropriate for patients suffering from severe chronic pain associated with low back pain (LBP) or osteoarthritis (OA). Efficacy studies of tapentadol (...) in populations of patients with severe chronic LBP or OA pain suggest that tapentadol is non-inferior to oxycodone. Its tolerability, especially with respect to gastrointestinal (GI) side effects, may be better than that of other strong opioids in clinical trials and analyses of multiple trials. Patient satisfaction with tapentadol extended release for chronic noncancer pain syndromes is good. Although tapentadol has an opioid component with abuse liability, it appears to be a difficult opioid for tampering

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2018 Pain and therapy

18. Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Surgery

Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Surgery Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Surgery - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please (...) remove one or more studies before adding more. Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Surgery The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03604354 Recruitment

2018 Clinical Trials

19. Does ‘Strong Analgesic’ Equal ‘Strong Opioid’? Tapentadol and the Concept of ‘µ-Load’ (PubMed)

Does ‘Strong Analgesic’ Equal ‘Strong Opioid’? Tapentadol and the Concept of ‘µ-Load’ The distinct properties of the centrally-acting analgesic tapentadol derive from the combined contributions of an opioid component and a nonopioid component. However, the opioid component's relative contribution to analgesic and adverse effects has not previously been elucidated. Tapentadol's analgesic effect derives from the combined contribution of an opioid mechanism and a nonopioid mechanism (...) , the extent of which can vary for different pains. Likewise, the interaction can vary for various adverse effects. Hence, the contribution of each mechanism to adverse effects can be different from the contribution to analgesia. We here estimate the percent contribution of each component of the mechanism of action to analgesia and to adverse effects.Several approaches to in vitro and in vivo data to estimate the contribution of tapentadol's opioid component to analgesia and to the two important opioid

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2018 Advances in therapy

20. Effects of tapentadol on pain, motor symptoms and cognitive functions in Parkinson’s disease (PubMed)

Effects of tapentadol on pain, motor symptoms and cognitive functions in Parkinson’s disease Pain is a common and undertreated non-motor symptom in patients with Parkinson's disease (PD). Opioids have been seldom used in PD because they could worsen cognitive and motor functions.We aimed to assess efficacy and tolerability of tapentadol in PD patients.We retrospectively reviewed 21 PD patients treated with tapentadol extended release (ER) for chronic pain. Patients were evaluated before (...) in cognitive neuropsychological performances was found and an improvement was observed in Digit Span test, Digit-Symbol Substitution test, and FAS test. The levels of anxiety, depression, and quality of life improved. Overall, tapentadol ER was well tolerated and most patients reported no or mild and short-lived gastroenterological and neurological side effects.These results indicate the potential efficacy and tolerability of medium-high doses of tapentadol ER for the treatment of pain in PD.

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2018 Journal of pain research

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