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The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.

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.