First Non-Medication Approved for RLS
FDA has granted commercial clearance for Relaxis, the first non-pharmacological approach to help improve the quality of sleep in patients with primary Restless Leg Syndrome (RLS). Sensory Medical Inc. developed the device and will market it in the US
The device represents the first prescription, noninvasive, non-medication alternative for improving quality of sleep in patients with primary Restless Leg Syndrome, according to Fred Burbank MD, Sensory Medical's chief executive officer. Relaxis was designed to provide physical relief of RLS while enabling the patient to remain in bed. During an RLS episode, the patient places the low-profile Relaxis pad at the site of their discomfort and chooses a vibration intensity. The device provides 30 minutes of vibratory counterstimulation, gradually ramping down and shutting off without waking the patient.
Results from two randomized, multi-center, controlled, double-blinded, prospective clinical research studies published in a peer-reviewed journal article indicated that the Relaxis device was found superior to placebo pads for improving sleep quality in patients with primary RLS.
Upper Airway Stimulation for Sleep Apnea Approved
Inspire Medical Systems has received marketing approval from the FDA for its Inspire Upper Airway Stimulation (UAS) system. The device is an implantable nerve stimulator used to treat moderate to severe obstructive sleep apnea (OSA). The system consists of implanted components including the implantable pulse generator (IPG), stimulation lead, and sensing lead and external components including the physician programmer and the patient programmer.
The IPG detects the patient's breathing pattern and maintains an open airway with mild stimulation of the hypoglossal nerve, which controls tongue movement, during inhaled breathing. The physician adjusts the stimulation settings using the external physician programmer. The patient sleep remote allows the patient to turn therapy on before they go to sleep and to turn therapy off when they wake up.
The Inspire UAS system is used to treat a subset of patients with moderate to severe OSA (apnea-hypopnea index [AHI] of greater or equal to 20 and less than or equal to 65). The Inspire UAS system is used in adult patients 22 years and older who have been confirmed to fail or cannot tolerate positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BPAP] machines) and who do not have a complete concentric collapse (as seen during drug induced sleep endoscopy) at the soft palate level.
Pain Generic Now Available
The FDA has approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.
Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100mg, 200mg, and 400mg strengths, and has 180-day exclusivity on the 100 mg, 200mg, and 400mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.
Celecoxib is a Non-Steroidal Anti-Inflammatory Drug (NSAID). All NSAIDs have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed Warning also highlights the risk of serious, potential life-threatening gastrointestinal (GI) bleeding that has been associated with use of NSAIDs.
In the clinical trials for Celebrex, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.
FDA Launches openFDA to Provide Access to FDA public Data
FDA has launched open.FDA.gov, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health data-sets collected by the agency.
In alignment with the recent Presidential Executive Order on Open Data and the Department of Health and Human Services Health Data Initiative, openFDA will make the FDA's publicly available data accessible in a structured, computer readable format that will make it possible for technology specialists, such as mobile application creators, web developers, data visualization artists and researchers to quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets on an as needed basis.
OpenFDA utilizes a search-based Application Program Interface (API) to collect large amounts of existing publicly available data, offering developers the ability to search through text within that data, ranking results much like a search using Google would do. This method then allows them to build their own applications on top of openFDA, giving them a large amount of flexibility to determine what types of data they would like to search and how they would like to present that data to end-users. This enables a wide variety of applications to be built on one common platform.
The initiative is the result of research with internal officials and external developers to identify those datasets that are in recurrent demand and are traditionally fairly difficult to use. Based on this research, the FDA decided to phase in openFDA beginning with an initial pilot program involving the millions of reports of drug adverse events and medication errors that have been submitted to the FDA from 2004 to 2013. Previously, the data was only available through difficult to use reports or Freedom of Information Act requests.
The Eyes Have It
A new optical method for brain scanning compares favorably with neuroimaging traditional techniques such as PET and MRI, but avoids the radiation exposure and bulky magnets the others require, according to new research published online May 18 in Nature Photonics. The new optical approach to brain scanning is ideally suited for children and for patients with electronic implants, such as pacemakers, cochlear implants and deep brain stimulators
The technology is called diffuse optical tomography (DOT). And while researchers have been developing it for more than 10 years, the method had been limited to small regions of the brain. The new DOT instrument covers two-thirds of the head and for the first time can image brain processes taking place in multiple regions and brain networks such as those involved in language processing and self-reflection (daydreaming).
For the current study, researchers from the School of Medicine at Washington University in St. Louis validated the performance of DOT by comparing its results to fMRI scans. Data was collected using the same subjects, and the DOT and fMRI images were aligned. They looked for Broca's area, a key area of the frontal lobe used for language and speech production. The overlap between the brain region identified as Broca's area by DOT data and by fMRI scans was about 75 percent.
In a second set of tests, researchers used DOT and fMRI to detect brain networks that are active when subjects are resting or daydreaming. Researchers' interest in these networks has grown enormously over the past decade as the networks have been tied to various different aspects of brain health and sickness, such as schizophrenia, autism and Alzheimer's disease (AD). In these studies, the DOT data also showed remarkable similarity to fMRI—picking out the same cluster of three regions in both hemispheres of the brain.
During DOT scans, the subject wears a cap composed of many light sources and sensors connected to cables. The full-scale DOT unit takes up an area slightly larger than an old-fashioned phone booth, but researchers say they are building versions of the scanner mounted on wheeled carts.
Video Atlas of Neuromuscular Diseases Released
A first of its kind video atlas of neuromuscular disorders is now available from author and Practical Neurology editorial board member Aziz Shaibani, MD. Video Atlas of Neuromuscular Diseases features video content supplemented with multiple-choice questions and updates on the illustrated topics. Short video clips from real clinic stories supplemented with challenging multiple choice questions bridges the gap between overflow of information and short attention span, according to Oxford University Press (http://global.oup.com/academic/product/a-video-atlas-of-neuromuscular-disorders-9780199898152?cc=us&lang=en#). The chapters are arranged according symptoms instead of diseases; diseases are listed in the index. Close to 300 video cases are included.
New Approach Slows Degeneration in Animal Model of Huntington's
Research presented at the 2014 Canadian Neuroscience Meeting shows that blocking a specific class of glutamate receptors, called extrasynaptic NMDA receptors, can improve motor learning and coordination, and prevent cell death in animal models of Huntington disease.
“After more than a decade of research on the pre-symptomatic phase of Huntington disease, markers are being developed to facilitate assessment of interventional therapy in individuals carrying the genetic mutation for Huntington disease, before they become ill. This will make it possible to delay onset of disease,” said Lynn Raymond MD, PhD, of the University of British Columbia.
The neurotransmitter glutamate has been known to promote cell death, and its toxic effects occur through the action of a family of receptors known as the NMDARs (N-methyl- D-Aspartate ionotropic glutamate receptors). Treating disorders of the nervous system by blocking NMDARs has not been successful because such treatments have too many side effects. A recent hypothesis based on work from scientists suggests that NMDARs located in different regions at the surface of neurons may have opposite effects, which would explain why blocking all NMDARs is not a good treatment option. A synapse is a structure that allows one neuron to connect to another neuron and pass an electrical or chemical signal between them. Many receptors for neurotransmitters are located in synapses, as these are the main area where these chemical signals are transmitted. However, receptors can also be found outside the synapse, and in this case are called extrasynaptic receptors. Many recent studies have revealed that NMDARs located at synapses act to increase survival signaling and promote learning and memory, whereas extra-synaptic NMDARs shut off survival signaling, interfere with learning mechanisms, and increase cell death pathways.
Dr. Raymond and her team were able, by using memantine, a drug that selectively blocks extra-synaptic NMDARs early, before the appearance of any symptoms, to delay the onset of Huntington-like symptoms in a mouse model of the disease. These promising results could lead to new treatment avenues for Huntington patients, and delay the appearance of symptoms. “Our results suggest that clinical studies of memantine and similarly-acting drugs in Huntington disease, particularly in the pre-symptomatic stage, are warranted,”says Dr. Raymond.
AHA/ASA Issue Scientific Statement Stressing Activity Post-Stroke
Physical activity and exercise prescription should be incorporated into the management of stroke survivors, according to a new scientific statement by the American Heart Association/American Stroke Association. The statement, based on an overview of the evidence on physical activity and exercise for stroke survivors, was published online in Stroke.
The authors said the promotion of physical activity in stroke survivors ought to “emphasize low- to moderate-intensity aerobic activity, muscle-strengthening activity, reduction of sedentary behavior, and risk management for secondary prevention of stroke.” To summarize existing evidence and indicate gaps in current knowledge, members of the group used systematic: literature reviews, references to published clinical and epidemiology studies, morbidity and mortality reports, clinical and public health guidelines, authoritative statements, personal files, and expert opinion.
“Physical inactivity after stroke is highly prevalent,” the authors wrote. “The assessed body of evidence clearly supports the use of exercise training (both aerobic and strength training) for stroke survivors. Exercise training improves functional capacity, the ability to perform activities of daily living, and quality of life, and it reduces the risk for subsequent cardiovascular events. Physical activity goals and exercise prescription for stroke survivors need to be customized for the individual to maximize long-term adherence.”