The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
AXS-05 consists of dextromethorphan, a noncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist, and bupropion, a norepinephrine and dopamine reuptake inhibitor that serves to increase the bioavailability of dextromethorphan.
The designation is supported by data from the multicenter, double-blind, placebo-controlled phase 2/3 ADVANCE-1 study that evaluated the efficacy and safety of AXS-05 in 366 AD patients with agitation. Patients were randomized to receive AXS-05, bupropion, or placebo. The primary end point was the change from baseline to week 5 in the Cohen-Mansfield Agitation Inventory (CMAI) total score.
Results demonstrated that AXS-05 was associated with a statistically significant mean reduction in the CMAI total score of 15.4 points at week 5 compared with 11.5 points for placebo (P =.01). Additionally, AXS-05 was found to be superior to bupropion based on CMAI total score (P <.001).
Regarding safety, AXS-05 was well tolerated and was not associated with cognitive impairment or sedation. The most commonly reported adverse reactions with AXS-05 included somnolence, dizziness, and diarrhea.
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