The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
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The Nonprescription Drugs Advisory Committee (NDAC) of the Food and Drug Administration (FDA) has recommended the approval of the New Drug Application (NDA) from GlaxoSmithKline for an over-the-counter (OTC) nicotine mouth spray to aid in smoking cessation (9 to 6 vote). The nicotine mouth spray (NMS) delivers 1mg nicotine per spray; each dispenser would deliver…
The trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America.