Showing 991-1000 of 1043 results for "".
- The FDA Accepts NDA for Oxybate Mixed Salts for Excessive Daytime Sleepinesshttps://practicalneurology.com/news/the-fda-accepts-nda-for-oxybate-mixed-salts-seeking-marketing-approval/2469209/The Food and Drug Administration (FDA) accepted a new drug application (NDA) for oxybate mixed salts (JZP-258, Jazz Pharmaceuticals, Philadelphia, PA). The oxybate mixed salts is an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness (EDS) in individuals age 7
- New Drug Application Submitted to FDA for A Novel Oxybate for Narcolepsy Symptomshttps://practicalneurology.com/news/new-drug-application-submitted-to-fda-for-a-novel-oxybate-for-narcolepsy-symptoms/2469138/A new drug application (NDA) for a novel oxybate (JZP-258; Jazz Pharmaceuticals; Philadelphia, PA) has been submitted to the Food and Drug Administration (FDA). The submission is based on a phase 3 global double-blind placebo-controlled study that demonstrated the efficacy and safety of the oxyba
- FDA Approves Percutaneous Endoscopic Administration of Riluzole for Treating ALShttps://practicalneurology.com/news/fda-approves-percutaneous-endoscopic-administraition-of-riluzole-for-treating-als/2469110/The Food and Drug Administration (FDA) has approved administration of riluzole oral suspension (TIGLUTIK; ITF Pharma Inc., Berwyn, PA) via percutaneous endoscopic gastronomy (PEG) tube for treating amyotrophic lateral sclerosis (ALS). The FDA approval is based on a study that showed the therapy i
- Alzheimer’s Survey Asks Caretakers What Type of Care is Needed for Different Stageshttps://practicalneurology.com/news/alzheimers-survey-asks-caretakers-what-type-of-care-is-needed-for-different-stages/2469070/A new survey, Alzheimer's Diseae in America 2019 (Health Union, Philadelphia, PA), finds types of care provided for individuals with Alzheimer's Disease (AD) varies with the stage of disease. Caregivers report that as AD progresses through 3 stages, the care they provide to their lo
- Sleep and Behavior a Growing Part of Alzheimer's Disease Researchhttps://practicalneurology.com/news/sleep-and-behavior-a-growing-part-of-alzheimers-disease-research/2469006/A new report from Elsevier Analytical Services (Philadelphia, PA) shows that sleep and behavior have become important topics within research for Alzheimer's disease (AD). The study shows that scientists who explore the connection between sleep and AD are developing new theories on the early w
- Women With Migraine More Likely to Have Babies With Colichttps://practicalneurology.com/news/women-with-migraine-more-likely-to-have-babies-with-colic/2468964/At the American Headache Society’s 61st Annual Meeting July 11-14 in Philadephia, PA, Dr. Amy Gelfand, associate professor of neurology and director of the pediatric headache program at the University of California, San Francisco, received the 2019 Harold G. Wolff Lecture Award. This award
- First Participant Enrolled in Study of ENT-01 for Parkinson's Disease Dementiahttps://practicalneurology.com/news/first-participant-enrolled-in-study-of-ent-01-for-parkinsons-disease-dementia/2468938/The first participant is enrolled in a clinical study of ENT-01(Enterin, Philadelphia, PA), a compound designed to reverse neurologic symptoms associated with Parkinson’s disease dementia (PDD). The aim of the DEMET study, an open-label multi-center trial, is to enroll 30 participants with
- Schedule IV Designation For Solriamfetol, a New Treatment for Excessive Daytime Sleepiness in Narcolepsy or OSAhttps://practicalneurology.com/news/schedule-iv-designation-for-solriamfetol-a-new-treatment-for-excessive-daytime-sleepiness-in-narcolepsy-or-osa/2468931/The Drug Enforcement Agency DEA has designated solriamfetol (Sunosi; Jazz Pharmaceuticals, Philadelphia, PA) a schedule IV agent, meaning that it has low potential for abuse or dependence. Solriamfetol was approved for treatment of excessive daytime sleepiness associated with narcolepsy or obstru
- Solriamfetol Efficacy and Safety for Treatment of Excessive Daytime Sleepiness in People With Narcolepsy or OSA Is Consistent Across Trialshttps://practicalneurology.com/news/solriamfetol-efficacy-and-safety-for-treatment-of-excessive-daytime-sleepiness-in-people-narcolepsy-or-osa-is-consistent-across-trials/2468928/Solriamfetol (Sunosi; Jazz Pharmaceuticals, Philadelphia, PA) has been approved by the Food and Drug Administration for the treatment of excessive daytime sleepiness in people with narcolepsy or obstructive sleep apnea (OSA) and is pending a scheduling decision from the Drug Enforcement Agency (D
- Patient Impact Award for Liquid Riluzole Treatment for ALShttps://practicalneurology.com/news/patient-impact-award-for-liquid-riluzole-treatment-for-als/2468821/The Patient Impact Award from Life Sciences Pennsylvania pharmaceutical company will be recognized in March for the US launch of the first easy-to-swallow, thickened riluzole liquid (Tiglutek; ITF Pharma, Berwyn, PA) for treating amyotrophic lateral sclerosis (ALS). The suspen