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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Publication date: Available online 19 February 2019Source: NeuronAuthor(s): Lucy A. McDermott, Greg A. Weir, Andreas C. Themistocleous, Andrew R. Segerdahl, Iulia Blesneac, Georgios Baskozos, Alex J. Clark, Val Millar, Liam J. Peck, Daniel Ebner, Irene Tracey, Jordi Serra, David L. BennettSummaryLoss-of-function mutations in NaV1.7 cause congenital insensitivity to pain (CIP); this voltage-gated sodium channel is therefore a key target for analgesic drug development. Utilizing a multi-modal approach, we investigated how NaV1.7 mutations lead to human pain insensitivity. Skin biopsy and microneurography revealed an absence ...
Source: Neuron - Category: Neuroscience Source Type: research
In conclusion, differences in both opioid and cannabinoid sensitivity between HA and LA mice could stem from alterations in intracellular second messenger mechanisms involving G-protein activation.
Source: Neuroscience - Category: Neuroscience Source Type: research
ConclusionsIt remains premature to declare superiority for uniportal VATS in lung cancer surgery. A higher level of evidence is needed, especially in investigating objective benefits and treatment efficacy of the single-incision approach.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
Authors: Almeida M, Saragiotto B, Maher CG PMID: 30776118 [PubMed - in process]
Source: Medical Journal of Australia - Category: General Medicine Tags: Med J Aust Source Type: research
CONCLUSIONS: Patients were evaluated more efficiently in the RACPC than in a traditional cardiology clinic, and their subsequent rates of emergency department re-attendances and adverse cardiovascular events were lower. PMID: 30773636 [PubMed - as supplied by publisher]
Source: Medical Journal of Australia - Category: General Medicine Tags: Med J Aust Source Type: research
A specific approach to mindfulness may increase sociability.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Medicine and Health Psychology and Psychologists Meditation Mobile Applications Anxiety and Stress Source Type: news
Authors: Di Salvo A, Chiaradia E, Della Rocca G, Giorgi M, Mancini F, Marenzoni ML, Conti MB, Nannarone S Abstract Intra-articular administration of analgesics is performed to ensure good perioperative pain management avoiding undesirable systemic effects. To evaluate the effect of intra-articular injection of tramadol on postoperative pain after arthroscopy in horses and to determine whether tramadol had a local effect. Before the in vivo study, an in vitro test was performed aiming to evaluate the viability of equine chondrocytes after exposure to various concentrations of tramadol. The concentration identified a...
Source: Veterinary Quarterly - Category: Veterinary Research Tags: Vet Q Source Type: research
Authors: Lenze EJ, Avidan MS PMID: 30773457 [PubMed - as supplied by publisher]
Source: The American Journal of Geriatric Psychiatry - Category: Psychiatry Tags: Am J Geriatr Psychiatry Source Type: research
Indivior Plc has launched a copycat of its blockbuster opioid addiction drug in the United States, the British drugmaker said on Wednesday, after losing a long-drawn court battle to prevent entry of generic rivals in its biggest market.
Source: Reuters: Health - Category: Consumer Health News Tags: healthNews Source Type: news
Depression and social anxiety in adolescents may be examined based on parental acceptance and rejection. The scale of quality of family interactions, the social anxiety scale and the state depression scale were used. Mothers' rejection and family satisfact...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
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