Investigational Agitation Treatment AXS-05 Named FDA Breakthrough Therapy

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, which can speed the approval process. “This FDA Breakthrough Therapy designation is an important milestone in the development of AXS-05 for Alzheimer’s disease agitation, a serious, prevalent, and debilitating condition for which there is currently no approved therapy,” Herriot Tabuteau, MD, CEO at Axsome, said in a press release. Thus far, there are no treatments that have been approved to treat agitation — an umbrella term that refers to feelings of restlessness, emotional distress, aggressio
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