Axsome’s Therapy for Agitation in Alzheimer’s Granted FDA Fast Track Designation

Axsome’s Therapy for Agitation in Alzheimer’s Granted FDA Fast Track Designation
Axsome Therapeutics’ investigational drug AXS-05 was recently granted fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of agitation in patients with Alzheimer's disease. The designation intends to speed up the development and regulatory handling of the drug, which is currently in the planning stage for a Phase 2/3 clinical trial. "Agitation is reported in nearly half of individuals living with Alzheimer’s disease, results in distress to patients and caregivers, and has significant consequences, including early nursing home placement and increased mortality," Herriot Tabuteau, MD, the CEO of Axsome, said in a press release. Symptoms come in the form of irritability, aggressive behaviors, emotional distress, and uninhibited behaviors. The symptoms are also linked to lower functional capacity, increasing the burden on caregivers and often leading to earlier placement in a nursing home. Treatments aimed at specific symptoms that might improve the quality of life of patients are increasingly important, especially with the recent failings in the development of drugs to treat or prevent Alzheimer’s. “The receipt of Fast Track designation from the FDA highlights the serious nature of this condition, the lack of FDA-approved treatments, and the potential of AXS-05 to address this high unmet medical need,” Tabuteau said. AXS-05 is a combination of the two drugs bupropion and dextromethorphan. Both have extensive actions on brain neurotransmission. In addition to these effects, bupropion also increases t
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