An exploratory, randomized, double-blind, double-dummy, placebo- and active-controlled Phase II trial to evaluate the efficacy and safety of a topical application of GRT7019 in subjects with chronic pain due to knee osteoarthritis

开始日期2017-07-18

申办/合作机构

Grünenthal GmbH

NCT00989040 / CompletedN/AIIT

Impact of Neuropathic Post-zosterian Pain on the Cognition (NPZ and Cognition)

Pain is defined as a sensorial and emotional phenomenon and lead consequences on the cognition. These consequences could be increased with usual treatment. So the aim of this study is to explore these cognitive consequences.

开始日期2009-03-01

申办/合作机构

Centre Hospitalier Universitaire de Clermont Ferrand

100 项与利多卡因/双氯芬酸依泊胺相关的临床结果

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100 项与利多卡因/双氯芬酸依泊胺相关的转化医学

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100 项与利多卡因/双氯芬酸依泊胺相关的专利（医药）

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项与利多卡因/双氯芬酸依泊胺相关的文献（医药）

2021-01-01·Applied health economics and health policy4区 · 医学

Effect of an Online Reimbursement Application System on Prescribing of Lidocaine 5% Medicated Plaster in the Republic of Ireland

4区 · 医学

Article

作者: Kennedy, Cormac ; Daly, Maria ; Doran, Stephen ; Barry, Michael ; Smith, Amelia

BACKGROUND:

The lidocaine 5% medicated plaster, Versatis^®, has one therapeutic indication listed on the Summary of Product Characteristics-symptomatic relief of post-herpetic neuralgia (PHN) in adults. Increased expenditure on Versatis^® suggests that there is considerable off-label use. To support the appropriate use of Versatis^®, the Health Service Executive's Primary Care Reimbursement Service (PCRS) introduced a reimbursement application system for Versatis^® from 1 September 2017.

OBJECTIVE:

The aim of this study was to investigate the effect of introducing a reimbursement application system on Versatis^® prescribing under the General Medical Services (GMS) scheme.

METHODS:

This study was carried out using prescription dispensing data from the PCRS pharmacy claims database. We carried out segmented linear regression to assess changes in the Versatis^® prescribing rate per 1000 GMS eligible population, before and after the introduction of the online reimbursement application system.

RESULTS:

The results of the segmented regression analysis show that there was a statistically significant level (- 4.91, p < 0.001) and trend change (- 0.69, p < 0.001) in the rate of Versatis^® prescribing post-introduction of the reimbursement application system. In the year prior to the introduction of the system, 2016, the annual GMS expenditure on Versatis^® lidocaine 5% patches was over €27 million, whereas the GMS expenditure in 2018 was reduced to just over €2 million.

CONCLUSION:

In our study, a substantial decrease in the dispensing of Versatis^® was seen after the implementation of a reimbursement application system. Prescribing of Versatis^® should be restricted to patients with a diagnosis of PHN not only to reduce costs, but to ensure evidence-based use of this medication.

2020-09-02·Expert review of pharmacoeconomics & outcomes research4区 · 医学

Combining health technology assessment and health technology management to deliver cost-effective prescribing and cost containment – the Irish experience

4区 · 医学

Review

作者: Smith, Amelia ; Barry, Michael

INTRODUCTION:

Health technology assessment (HTA) is a widely used process to systematically evaluate the properties, effects, and impacts of health technology, with the main purpose of informing policymaking in healthcare. However, to ensure optimal use of scarce healthcare budgets, there is a need to look beyond HTA - to post-reimbursement health technology management (HTM).

AREAS COVERED:

This review aims to describe the significant impact HTA, in combination with HTM, has made to the cost-effective prescribing and cost-containment in Ireland. This review will cover a number of specific examples, such as; specific reimbursement criteria for sacubitril/valsartan (Entresto®) and evolocumab (Repatha®), the introduction of a reimbursement application system for lidocaine 5% medicated plaster (Versatis®), and the introduction of 'preferred' biosimilars for patent-expired biologic medicines.

EXPERT OPINION:

Healthcare payers are increasingly recognizing the benefits of HTM particularly when used in conjunction with HTA. This review highlights several examples whereby significant cost-savings can be made through HTM of not only new drugs but also drugs which are already available on the market.

2018-10-01·Minerva medica4区 · 医学

Efficacy of lidocaine 5% medicated plaster (VERSATIS®) in patients with localized neuropathic pain poorly responsive to pharmacological therapy

4区 · 医学

Article

作者: Zanzotti, Michele ; Chinellato, Eris ; Tamburin, Stefano ; Schweiger, Vittorio ; Polati, Enrico ; Del Balzo, Giovanna ; Parolini, Massimo ; Picelli, Alessandro ; Martini, Alvise

BACKGROUND:

Localized neuropathic pain (LNP) is a subgroup of neuropathic pain characterized by consistent and circumscribed area(s) of maximum pain, associated with negative or positive sensory signs and/or spontaneous symptoms characteristic of NP. Lidocaine medicated plasters (LMP) have shown to be effective in pain relief in selective LNP syndromes.

METHODS:

We collected data of 130 patients in our database with LNP syndromes who used LMP.

RESULTS:

Forty-one patients out of 130 patients (32%) were treated with antiepileptics, antidepressants and opioids without improvement and/or with intolerable adverse effects and are not assuming systemic therapy anymore. Globally, during the 12 months follow-up, 15% of patients reached a complete pain relief without any systemic therapy, mainly in trigeminal and post-herpetic neuralgia (P=0.009), 38% of patients reduced analgesic drug consumption with the highest reduction in radiculopathy, post-herpetic neuralgia and trigeminal neuralgia. Topical and transient adverse effects, such as itching or local erythema, were seen in 19/130 (14.6%) patients; 7 of these patients (5.4%) needed to discontinue the treatment due to the occurrence of adverse effects. The dropout rate on global population (excluding cured and lost to follow-up) was 45%, and the main cause of dropouts was the inefficacy of treatment in the first 3 months of therapy with LMP.

CONCLUSIONS:

LMP treatment is safe and worth consideration also as add-on therapy in order to reduce analgesic drug consumption in selected LNP.

项与利多卡因/双氯芬酸依泊胺相关的新闻（医药）

2024-05-30

·PRNewswire

Teikoku Pharma USA, Inc. Announces NMPA Approved Lidoderm® in China on May 8, 2024

SAN JOSE, Calif., May 30, 2024 /PRNewswire/ -- Teikoku Pharma USA (TPU) announced today that the NMPA (National Medical Products Administration) has approved Lidoderm® ("lidocaine 5% patch as lidocaine cataplasms") for the treatment of Post Herpetic Neuralgia (PHN) in China. TPU entered into an exclusive licensing agreement with Link Healthcare Group (LHG) in 2018 to develop and distribute Lidoderm® in China. Lidoderm® offers a topical and non-systemic approach for the treatment of neuropathic pain symptoms associated with PHN. Following a once daily 12 hours on/12 hours off application schedule, up to three patches can be used at one time. In the US, Lidoderm® is marketed by TPU Pharma (subsidiary of TPU) and its authorized generic lidocaine patch 5% is marketed by Endo USA, Inc. It is also marketed as Versatis® in Europe and Latin America by Grünenthal GmbH. Our lidocaine patch 5% has been marketed by our partners worldwide and over 3.7 billion patches have been delivered to patients since its launch. "Although this has been a long journey, we are happy to see Lidoderm® receive approval in China, an important market for our product that will also impact the lives of those suffering with Post Herpetic Neuralgia" said Paul Mori, CEO About Teikoku Pharma USA In collaboration with worldwide partners, TPU distributes its products to key markets globally. TPU excels not only in topical external preparations such as hydrogels, tapes and ointments, but also in systemic transdermal patches, solidifying its position as industry experts. Lidoderm® is a hydrogel patch that contains 5% lidocaine. It offers a topical approach for the treatment of neuropathic pain symptoms associated with PHN. For the product and important safety information, please consult the prescribing information; Prescribing Information (tpupharma.com) If you have any questions, please contact Francisco Bejar: [email protected] SOURCE Teikoku Pharma USA, Inc.

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100 项与利多卡因/双氯芬酸依泊胺相关的药物交易

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