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FDA Turns to Emerging Tech for Opioid Crisis

It will take more than medication alone to win the battle against opioid addiction, and now U.S. clinicians finally have a device-based therapy to help reduce the symptoms of opioid withdrawal. FDA granted a new indication to Innovative Health Solutions for its NSS-2 Bridge nerve stimulator. The new indication was reviewed under FDA's de novo pathway. “There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy,” said FDA Commissioner Scott Gottlieb, MD. Gottlieb said FDA supports the development of both drug and device-based treatments that can be used to address opioid dependence or addiction, as well as new, non-addictive treatments for pain that can serve as alternatives to opioids. The NSS-2 Bridge device is a small electrical nerve stimulator placed behind the patient’s ear. It contains a battery-powered chip that emits electrical pulses to stimulate branches of certain cranial nerves. Such stimulations may provide relief from opioid withdrawal symptoms, the agency noted. The device is placed behind the ear with microneedle arrays that percutaneously implant in and around the ear. Patients can use the device for up to five days during the acute physical withdrawal phase. Opioid withdrawal causes acute physical withdrawal symptoms including sweating, gastrointestinal upset, agitation, insomnia, and...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

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CONCLUSIONS: Non-pharmacological approaches to pain in residential care settings are effective, especially when two or more are combined. Staff working in residential care settings should rely on best practice to recognise pain in residents with dementia. CLINICAL IMPLICATIONS: Non-pharmacological interventions may be effective in reducing pain and reliance on PRN medications in residential care settings, especially when two or more are used. Staff working in residential aged care settings should be provided with training in pain assessment and management, with particular attention to residents with dementia. PMID:...
Source: Clinical Gerontologist - Category: Geriatrics Tags: Clin Gerontol Source Type: research
CONCLUSIONS: Twelve-week costs per additional responder were lower for ixekizumab Q2W than for etanercept BIW across all levels of clearance (PASI 75, PASI 90, and PASI 100) in the pooled UNCOVER-2/UNCOVER-3 overall and US subgroup ITT populations. J Drugs Dermatol. 2017;16(12):1246-1252.. PMID: 29240860 [PubMed - in process]
Source: Journal of Drugs in Dermatology - Category: Dermatology Tags: J Drugs Dermatol Source Type: research
Conclusions: Findings support the effectiveness of apremilast in patients with moderate to severe psoriasis in dermatology clinical practices. Patients perceived apremilast to be effective. J Drugs Dermatol. 2017;16(12):1240-1245.. PMID: 29240859 [PubMed - in process]
Source: Journal of Drugs in Dermatology - Category: Dermatology Tags: J Drugs Dermatol Source Type: research
Authors: Kalhun V, Sadick N Abstract Biologic drugs, a novel class of agents engineered to target specifc mediators of infammation, and small-molecule inhibitors that pen-etrate the cell membrane to interact with targets inside a cell represent the cutting-edge of pharmacological biomedical therapeutics. Clinical studies have already demonstrated the effectiveness of this new generation of drugs in treating a variety of medical illnesses and conditions that were refractory to traditional treatments. This review aims to describe the latest available or currently in-develop-ment drugs, biologic agents, and small mole...
Source: Journal of Drugs in Dermatology - Category: Dermatology Tags: J Drugs Dermatol Source Type: research
This article reviews the most recently published clinical evidence of adjunctive use of topical agents with biologics, conventional systemic agents, and phototherapy, to better establish the role of topical agents in combination therapy for the treatment of psoriasis. J Drugs Dermatol. 2017;16(12):1209-1222.. PMID: 29240856 [PubMed - in process]
Source: Journal of Drugs in Dermatology - Category: Dermatology Tags: J Drugs Dermatol Source Type: research
Social media groups that bring together patients, family, friends and healthcare providers can improve patients ’ outlook and reduce their anxiety and depression, a recent U.S. study suggests.Reuters Health Information
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Medscape Today News Source Type: news
Abstract PURPOSE: To compare the outcome of dental implants placed following full-thickness flap surgery with flapless surgery in controlled type 2 diabetic patients. MATERIALS AND METHODS: A total of 92 controlled type 2 diabetic patients, who needed missing mandibular first molars to be replaced by implants, were selected for a single-centre, parallel group, double-blinded randomised controlled trial. Patients were randomly allocated into two groups: flap (46 patients) vs flapless (46 patients) implant placement. Implants were loaded with metal-ceramic crowns, 4 months after placement in both groups. O...
Source: European Journal of Oral Implantology - Category: Dentistry Authors: Tags: Eur J Oral Implantol Source Type: research
Authors: Lee G, Kim W Abstract The Locus Coeruleus (LC) is a small collection of noradrenergic neurons located in the pons. In the brain, noradrenaline (NE) is primarily produced by noradrenergic cell groups in the LC, which is the largest group of noradrenergic neurons in the central nervous system. Acupuncture, including the electroacupuncture which is a modified acupuncture method, is known to be effective in various kinds of diseases, and the involvement of noradrenergic system in the central nervous system has been reported by previous studies. However, on whether acupuncture can modulate the LC neuronal cells...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Conclusions: The BJK remedy extract showed equal clinical efficacy in relieving symptoms of OA knee when compared with diclofenac. PMID: 29234447 [PubMed]
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Authors: Han M, Sun Y, Su W, Huang S, Li S, Gao M, Wang W, Wang F, Fang Z, Zhao H Abstract Background: Many previous studies have shown the potential therapeutic effect of acupuncture for metabolic syndrome (MetS). However, most of these studies were limited by short durations of observation and a lack of sham acupuncture as control. We designed a randomized controlled trial, used sham acupuncture as the control, and evaluated the efficacy over 12 weeks of treatment and 12 weeks of follow-up. Methods/Design: The study was designed as a multicentre, parallel-group, randomized, double-blinded trial. 40 patients w...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
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