Showing 1571-1580 of 1732 results for "".
- FDA Clears Intranasal Foralumab for Clinical Investigation as a Potential Treatment for Alzheimer Diseasehttps://practicalneurology.com/news/fda-clears-intranasal-foralumab-for-clinical-investigation-as-a-potential-treatment-for-alzheimer-disease/2470269/Tiziana Life Sciences’ (New York, NY) investigational new drug (IND) application for intranasal foralumab has been cleared by the Food and Drug Administration (FDA), authorizing further investigations into the agent&r
- FDA Approves Film Formulation of Migraine Drughttps://practicalneurology.com/news/fda-approves-film-formulation-of-migraine-drug/2470157/The Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for a film formulation of rizatriptan benzoate (Rizafilm VersaFilm; IntelGenx Corp, Saint-Laurent, Quebec, Canada) for the treatment of acute
- Dry Powder Formulation of Dihydroergotamine Adheres to Nasal Lining and Safely Treats Migrainehttps://practicalneurology.com/news/dry-powder-formulation-of-dihydroergotamine-adheres-to-nasal-lining-and-safely-treats-migraine/2469937/In the ASCEND (NCT04406649) safety and tolerability study, a novel dry powder formulation of dihydroergotamine (DHE) (STS101; Satsuma Pharmaceuticals, South San Francisco, CA) was found safe and tolerable for use as an acute treatment
- Intranasal Foralumab Provides Neuroimaging and Clinical Improvements in Secondary Progressive Multiple Sclerosishttps://practicalneurology.com/news/intranasal-foralumab-provides-neuroimaging-and-clinical-improvements-in-secondary-progressive-multiple-sclerosis/2469929/In the expanded access program, after 3 months of intranasal foralumab (Tiziana Life Sciences, New York, NY) treatment of secondary progressive multiple sclerosis (SPMS), a second participant showed clinical improvement on Positron Emission Tomography (PET) imaging analysis, neurologic exami
- Subcutaneous Formulation of Carbidopa/Levodopa for Parkinson Disease Submitted to FDA for Approvalhttps://practicalneurology.com/news/subcutaneous-formulation-of-carbidopalevodopa-for-parkinson-disease-submitted-to-fda-for-approval/2469915/A new drug application was submitted to the FDA for a new formulation of of foscarbidopa/foslevodopa (CD/LD) (ABBV-951; Abbvie, Chicago, IL) delivered subcutaneously for treatment of Parkinson disease (PD). In a clinical trial (
- FDA Approves Transdermal Formulation of Donepezil for Alzheimer Diseasehttps://practicalneurology.com/news/fda-approves-transdermal-formulation-of-donepezil-for-alzheimer-disease/2469848/The Food and Drug Administration (FDA) has approved a transdermal formulation of donepezil (Adlarity; Corium, Boston, MA) for treatment of mild, moderate, or severe dementia from Alzheimer disease (AD). The transdermal patch delivers 5 or 10 mg/day for 7 days. This formulation is
- Once-Nightly Oxybate Formulation Effective and Preferred by People With Narcolepsyhttps://practicalneurology.com/news/once-nightly-oxybate-formulation-effective-and-preferred-by-people-with-narcolepsy/2469726/Post hoc analysis of data from the pivotal phase 3 REST-ON trial showed a once-nightly formulation of sodium oxybate (ON-SXB)(FT218; Avadel Pharmaceuticals, Dublin, Ireland), reduced weekly cataplexy attacks and improved sleep latency compared with placebo. Among participants who receiv
- FDA Approves New Occlusion System for Treatment of Patent Foramen Ovale to Prevent Recurrent Strokehttps://practicalneurology.com/news/fda-approves-new-occlusion-system-for-treatment-of-patent-foramen-ovale-to-prevent-recurrent-stroke/2469706/The Food and Drug Administration (FDA) has approved a new occluder (Amplatzer Talisman; Abbot, Chicago, IL) for treatment of patent foramen ovale (PFO) in individuals at risk of a recurrent stroke. The FDA also cleared the delivery sheath, used to del
- Once-A-Night Formulation of Sodium Oxybate Improves Excessive Daytime Sleepiness and Reduces Catplexy in Narcolepsyhttps://practicalneurology.com/news/once-a-night-formulation-of-sodium-oxybate-improves-excessive-daytime-sleepiness-and-reduces-catplexy-in-narcolepsy/2469669/Data from a pivotal phase 3 clinical study published in Sleep reveal that an investigational formulation of sodium oxybate (FT218; Avadel Pharmaceuticals, Dublin, Ireland), taken only once
- FDA Accepts New Drug Application for New Dihydroergotamine Formulation for Acute Treatment of Migrainehttps://practicalneurology.com/news/fda-accepts-new-drug-application-for-new-dihydroergotamine-formulation-for-acute-treatment-of-migraine/2469479/The Food and Drug Administration (FDA) has accepted the new drug application (NDA) for a new formulation of dihydroergotamine (DHE) (inp104; Trudhesa; Impel Neuropharma, Seattle, WA) for the acute treatment of migraine with or without aura. If approved, this formulation of DHE will be the first t