Investigational Agitation Treatment AXS-05 Named FDA Breakthrough Therapy

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Axsome Therapeutics‘ AXS-05, an investigational oral therapy for the treatment of agitation in people with Alzheimer’s disease. This designation is intended to accelerate the development and review of potential therapies for serious diseases. It is awarded upon clinical evidence of substantial improvement over existing treatment options. The program’s features include more intensive FDA guidance throughout treatment development, and eligibility for priority review,…

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