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 15 November 2018Source: The Veterinary JournalAuthor(s): James Hunt, David Knazovicky, Duncan Lascelles, Jo MurrellAbstractEvaluation of the response to externally applied physical stimuli, such as pressure, heat, or cold is termed Quantitative Sensory Testing (QST). QST may be used to identify and quantify alterations (gain or loss) in function of the sensory systems which detect and mediate these phenomena in both man and animals, and potentially discriminate peripheral and central sensitisation. It has been postulated that evaluation of QST parameters may predict response to analgesics...
Source: The Veterinary Journal - Category: Veterinary Research Source Type: research
This study retrospectively investigated the efficacy of the ESP block in pain management after lumbar spinal surgery. Methods: Patients who underwent lumbar spinal surgery in 2017 were enrolled in the study. Those who underwent secondary surgery with local anesthesia other than the ESP block were excluded. The primary outcome was the Numerical Rating Scale (NRS) pain score at various time points until the morning of postoperative day 2. The secondary outcomes were the amount of intravenous fentanyl administered during the first 24 hours following the surgery and the number of patients with complaints of complications s...
Source: Asian Spine Journal - Category: Orthopaedics Tags: Asian Spine J Source Type: research
We describe the clinical case of a 9-year-olf-female with recurrent monthly episodes of fever, arthralgia, abdominal pain, and urticaria-angioedema who did not respond to steroids associated with antihistamines, however showed the complete resolution of the disease with omalizumab. PMID: 30426806 [PubMed - as supplied by publisher]
Source: Journal of Dermatological Treatment - Category: Dermatology Tags: J Dermatolog Treat Source Type: research
Authors: van Egmond N, van Grinsven S, van Loon CJ Abstract The short-term clinical and radiographic outcomes of two different valgus unloading braces were compared in patients with medial knee osteoarthritis (OA) and a varus leg alignment. A RCT was performed in 100 patients (50 Bledsoe Thruster brace, 50 SofTec OA brace) with symptomatic medial knee OA and a varus leg alignment. Outcomes were the visual analogue scale pain and satisfaction, Dutch Western Ontario and McMaster Universities Osteoarthritis Index, SF-12, 6-Minutes Walking Test, hip-knee-ankle alignment, analgesic use, complications and compliance afte...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
Authors: Wu CC Abstract Some non-surgical techniques that decrease the mechanical load of the knee may be effective in treating early primary knee osteoarthritis. Thirtysix consecutive patients with bilateral early primary knee osteoarthritis and genu varum were treated with unilateral proximal tibial osteotomy in the more degenerated knee. After the osteotomized bone healed, ambulation with protected weight bearing using a cane in the contralateral hand was advised continuously for at least three months or until knee pain subsided bilaterally. Thirty-one patients were followed for an average of 4.6 years (range, 2...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
Authors: Kilinc CY, Kilinc B, Acar E, Kilinc RM, Aykut S, Oznur A Abstract To perform an Akin osteotomy using suture anchors to achieve stability of the osteotomy line and avoid the need for a further operation to remove an implant. Akin osteotomy using suture anchors was performed on 35 feet of 30 patients (21 female, 9 male ; mean age 45 years, range 18-60 yrs) diagnosed with hallux valgus. In bilateral cases, surgery was firstly carried out on the foot in the more serious condition, followed by the second foot 2 months later. Preoperative and postoperative clinical evaluation of the patients was made using Ameri...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
E-cigarettes may help tobacco smokers quit. But the alluring devices can swiftly induce a nicotine habit in teenagers who never smoked. The tale of one teen ’ s struggle.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Smoking and Tobacco Addiction (Psychology) Nicotine Teenagers and Adolescence E-Cigarettes Juul Food and Drug Administration Source Type: news
Millions embrace e-cigarettes as smoking cessation aids. Will restricting the devices for teenagers put former adult smokers who vape at risk to start again?
Source: NYT Health - Category: Consumer Health News Authors: Tags: Smoking and Tobacco Addiction (Psychology) Nicotine E-Cigarettes Food and Drug Administration Juul Labs Inc Source Type: news
This study shows the rates of depression, anxiety and other mental health conditions among LGBT people.
Source: Current Awareness Service for Health (CASH) - Category: Consumer Health News Source Type: news
Health experts: North Korea is facing shortage of tuberculosis medications that could accelerate spread of more deadly strain, putting hundreds of thousands at risk
Source: ABC News: Health - Category: Consumer Health News Tags: Health Source Type: news
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