DermWire | Newest Articles Newest Articles en-us Thu, 19 Oct 2017 03:42:41 GMT Thu, 19 Oct 2017 03:42:41 GMT DermWire National Grant Awarded to Mount Sinai to Continue the New York Traumatic Brain Injury Model System The National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR) has awarded the Icahn School of Medicine at Mount Sinai’s Department of Rehabilitation Medicine and the Brain Injury Research Center a five-year grant totaling $2.2 million to fund the New York Traumatic Brain Injury Model System at Mount Sinai to study traumatic brain injury (TBI). The grant will fund the work of researchers who will contribute to the largest study of TBI outcomes in the world, … Wed, 18 Oct 2017 04:00:00 GMT Once-Daily Lyrica Formulation Wins FDA Approval The FDA has approved Lyrica CR (pregabalin, Pfizer) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). The efficacy and safety of the new formulation was established in a randomized placebo-controlled clinical trial conducted in which 801 patients with PHN entered a six-week single-blind treatment with Lyrica CR followed by a 13-week double-blind phase. … Thu, 12 Oct 2017 04:00:00 GMT Next-Generation VNS System and Implantable Device Approved LivaNova has received FDA approval for its next-generation Vagus Nerve Stimulation (VNS) Therapy Programming System for drug-resistant epilepsy. The FDA has also approved the company's SenTiva implantable device, the smallest and lightest responsive therapy for epilepsy. The new VNS Therapy system features a wireless wand and new user interface on a small tablet, while the SenTiva device includes detect-and-respond mode designed to prevent seizures before they start and automatically deliver… Mon, 9 Oct 2017 04:00:00 GMT FDA Greenlights Two Generic Glatiramer Acetate Formulations for Relapsing MS The FDA approved Mylan’s generic versions of glatiramer acetate, including a three-times weekly 40mg/mL formulation of glatiramer acetate and a once-daily 20mg/mL formulation. As part of its Abbreviated New Drug Applications, Mylan submitted side-by-side analyses, including characterization data, demonstrating that its formulations have the same active ingredient, dosage form, route of administration, and strength as their branded counterpart Copaxone (Teva). Because Mylan was one of the f… Wed, 4 Oct 2017 04:00:00 GMT US Postal Service Issues Alzheimer’s Disease Semipostal Stamps New stamps for Alzheimer’s disease awareness are coming soon from the US Postal Service. Under its semipostal discretionary program, the Postal Service will issue five stamps over a 10-year period to advance causes it considers to be “in the national public interest and appropriate,” with each stamp to be sold for no more than two years. The Alzheimer’s Semipostal Stamp will be issued during National Alzheimer’s Awareness Month and net proceeds will be distributed t… Mon, 2 Oct 2017 04:00:00 GMT Investigational Low-Dose Fenfluramine Shows Promise in Phase 3 Trial for Dravet Syndrome Phase 3 findings suggest that the investigational ZX008 (low-dose fenfluramine hydrochloride, Zogenix) is effective for the treatment of Dravet syndrome. The study enrolled 119 patients across sites in the US, Canada, Europe, and Australia with a median age of patients was eight years. Following a six-week baseline observation period, patients were randomized to one of three treatment groups: ZX008 0.8mg/kg/day (30mg maximum daily dose), ZX008 0.2 mg/kg/day and placebo in which ZX008 or placebo … Fri, 29 Sep 2017 04:00:00 GMT FDA Approves Intellis Device for Intractable Pain The FDA has approved the Intellis platform (Medtronic) for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems and can power the EvolveSM workflow*, which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings. The Intellis platform can record and track patient activity and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physician… Wed, 20 Sep 2017 04:00:00 GMT Benefits of PFO Closure Confirmed in Publication of Trial Data Recently published data in The New England Journal of Medicine from three different studies show that closing a patent foramen ovale (PFO) significantly reduces the rate of recurrent stroke compared with medical therapy in patients who experienced a cryptogenic stroke and had a PFO. In the RESPECT study, the Amplatzer PFO Occluder (St. Jude Medical/Abbott Laboratories) was associated with a 45 percent reduction in the risk of ischemic stroke and a 62 percent reduction in the rate of cryptogen… Fri, 15 Sep 2017 04:00:00 GMT Briviact Approved as Monotherapy for Partial-Onset Seizures The FDA has approved a supplemental new drug application for Briviact (brivaracetam, UCB) CV as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy. Briviact is the newest antiepileptic drug in the ‘racetam’ class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with… Fri, 15 Sep 2017 04:00:00 GMT Aptiom Approved for Partial-Onset Seizures in Patients Four Years of Age and Older The FDA has approved the supplemental New Drug Application (sNDA) to expand the indication for Aptiom (eslicarbazepine acetate, Sunovion) to include treatment of partial-onset seizures in children and adolescents four to 17 years of age. The approval was based on FDA guidance that permits the extrapolation of data to support pediatric use. The safety and efficacy of APTIOM as monotherapy and adjunctive therapy for the treatment of POS in adults was established in five multicenter, randomized, co… Thu, 14 Sep 2017 04:00:00 GMT 17 New Genes Linked to Parkinson’s Disease A new study has discovered 17 novel genetic variants associated with Parkinson’s disease, several of which are considered targets for intervention. Published in Nature Genetics, the genome-wide association study represents a collaboration between Genentech and the personal genomics company 23andMe. Investigators compared 6,476 PD cases with 302,042 controls as well as a meta-analysis of over 13,000 PF cases, 95,000 controls and 9,830 overlapping variants. Using a neurocentric strategy to a… Thu, 14 Sep 2017 04:00:00 GMT Vitamin D Levels Tied to Risk of MS Examining vitamin D levels in the blood may help predict whether a person is at risk of developing multiple sclerosis (MS), according to a large new study published Neurology (September 13). Using a repository of blood samples from more than 800,000 women in Finland, taken as part of prenatal testing, investigators identified 1,092 women who were diagnosed with MS an average of nine years after giving the blood samples. These samples were compared to those of 2,123 women who did not develop the … Thu, 14 Sep 2017 04:00:00 GMT Blood Test Shown to Accurately Identify Alzheimer’s Disease A blood test may help identify and diagnose Alzheimer’s disease. In a study published in Proceedings of the National Academy of Sciences of the United States of America, researchers used attenuated total reflection FTIR (ATR-FTIR) spectroscopy combined with chemometric techniques to analyze blood plasma samples in 347 individuals with neurodegenerative disease. They identified Alzheimer’s disease with 70% sensitivity and specificity, which after the incorporation of APOE 4 genotype, … Mon, 11 Sep 2017 04:00:00 GMT Project ALS and Amylyx Team Up to Test Phase 2 Compound Project ALS and Amylyx Pharmaceuticals are collaborating to undertake pre-clinical studies to advance the understanding of Amylyx's oral compound AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The studies will be conducted at the Project ALS Pre-Clinical Core at Columbia University's Motor Neuron Center and will complement the company's recently initiated Phase 2 clinical program of AMX0035 for the treatment ALS. The Project ALS Pre-Clinical Core at the Columbia Un… Thu, 7 Sep 2017 04:00:00 GMT CLARITY Extension: Annual Short-Course Therapy with Investigational Oral Agent Effective in Relapsing MS New results suggest that patients with relapsing multiple sclerosis (MS) treated with two annual short courses of the investigational cladribine tablets (EMD Serono) may have similar clinical benefits to those seen with four years of treatment with cladribine tablets. Published in the Multiple Sclerosis Journal, the data from the CLARITY Extension study assessed annualized relapse rate and confirmed three-month EDSS progression among other efficacy endpoints in 806 patients with relapsing MS. Th… Tue, 5 Sep 2017 04:00:00 GMT Study: Women and Men with APOE Epsilon 4 Gene at Equal Risk for Alzheimer’s Disease Although women with the APOE e3/e4 genotype have been thought to be at greater risk for Alzheimer’s disease, new research suggests that men and women between 55 and 85 years of age with the genotype have nearly the same odds of developing the disease. Reviewing data on nearly 58,000 participants from the Global Alzheimer’s Association Interactive Network, researchers sought to determine the extent to which sex and APOE genotype affect the risks for developing MCI and AD (JAMA Neurol.… Thu, 31 Aug 2017 04:00:00 GMT Austedo Approved for Treatment of Tardive Dyskinesia The FDA has approved Austedo (deutetrabenazine, Teva Pharmaceutical Industries Ltd.) tablets for the treatment of tardive dyskinesia in adults. The approval was based on results from two Phase 3 randomized placebo-controlled studies assessing the efficacy and safety of Austedo in reducing the severity of abnormal involuntary movements associated with tardive dyskinesia (AIM-TD and ARM-TD). Austedo is the second drug approved for the treatment of tardive dyskinesia this year, joining Ingrezza … Thu, 31 Aug 2017 04:00:00 GMT AstraZeneca and Takeda Strike $400 Million Development Deal for Investigational Parkinson’s Agent AstraZeneca and Takeda Pharmaceutical Company Limited will jointly develop and commercialize an investigational alpha-synuclein antibody currently in development for the treatment of Parkinson’s disease (PD) known as MEDI1341. Differentiated by its high affinity, high selectivity, and reduced effector function (lower interaction with the immune system), MEDI1341 has the potential to achieve a better efficacy and safety profile than other alpha-synuclein antibodies, according to the two com… Tue, 29 Aug 2017 04:00:00 GMT Adamas: FDA Approves Gocovri for Dyskinesia FDA has approved Adamas Pharmaceuticals, Inc.’s Gocovri (amantadine) extended release capsules (previously ADS-5102) for treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Gocovri, previously granted orphan drug status by the FDA, is the first and only medicine approved by the FDA for this indication. Gocovri is a high dose 274mg amantadine (equivalent to 340mg amantadine HCl) taken onc… Fri, 25 Aug 2017 04:00:00 GMT Gut Bacteria May Play Preventive Role in MS New findings support the increasingly prominent hypothesis that gut bacteria play a role in autoimmune diseases such as multiple sclerosis (MS). Specifically, a study published in Cell Reports (Aug;20(6):1269-1277) shows that a bacteria present in the gut known as Prevotella histicola may possibly prevent MS. In the study, investigators found that Prevotella histicola can suppress experimental autoimmune encephalomyelitis (EAE) in a human leukocyte antigen (HLA) Class II transgenic mouse model. … Tue, 15 Aug 2017 04:00:00 GMT Stroke Rates Decreasing Among Men, Steady in Women Although stroke incidence rates are dropping overall, new findings suggest that those decreases are only seen in men. In a new study published in Neurology (published online August 9), investigators tracked all incident strokes among a population of 1.3 million at four specific periods in time: 1993-1994, 1999, 2005, and 2010. They found that rates of stroke incidence decreased over time in men but not in women. Additionally, rates were similar between women and men by 2010. The authors suggeste… Thu, 10 Aug 2017 04:00:00 GMT Recently Approved ALS Treatment Radicava Now Available Radicava (edaravone, Mitsubishi Tanabe Pharma America), an intravenous therapy indicated for all adult patients diagnosed with amyotrophic lateral sclerosis (ALS), is now available for treatment in the United States. The first FDA-approved ALS treatment option in more than 20 years, Radicava has been shown to slow the decline in the loss of physical function in ALS patients by 33 percent. Administered in 28-day cycles through an IV, patients can undergo treatment at an ALS center, physician&rsqu… Tue, 8 Aug 2017 04:00:00 GMT Non-Invasive Neuromodulation Device for Chronic Intractable Pain Cleared by FDA The FDA has cleared the Stimpod NMS460 (Xavant Technology), a non-invasive neuromodulation device for the symptomatic relief and management of chronic intractable pain. When applied to the affected area transcutaneously, the device’s proprietary hybrid pulsed radio frequency (PRF) waveform creates electromagnetic effects similar to invasive pulsed radio frequency treatments. It also incorporates nerve-locating technology, featuring a nerve-mapping probe that enables practitioners to locate… Tue, 1 Aug 2017 04:00:00 GMT Largest CTE Study in Football Players to Date Finds Pathological Diagnosis in 110 out of 111 NFL Players The already compelling evidence tying football to chronic traumatic encephalopathy (CTE) is now even stronger, with the publication of findings from the largest study yet to evaluate the brains of deceased football players. In a continuation of a study from several years ago, investigators neuropathologically diagnosed CTE in 177 of 202 brains of deceased football players. The study evaluated football players at various levels of play. A diagnosis of CTE was made in zero out of two pre-high s… Tue, 25 Jul 2017 04:00:00 GMT FDA Clears First MRI System for Neonatal Brain Imaging The FDA cleared the Embrace Neonatal MRI System, the first of its of its king specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). The Embrace Neonatal MRI System may be used on neonates with a head circumference up to 38 centimeters and weight between 1 and 4.5 kilograms. The system has a temperature-controlled incubator placed directly into the MRI system, minimizing movement of the baby. If urgent access to the baby is necessary during the imaging process,… Fri, 21 Jul 2017 04:00:00 GMT