AXS-05 is a medication that Axsome Therapeutics is developing for the treatment of agitation in patients with Alzheimer’s disease. The oral medication combines two compounds: bupropion and dextromethorphan.
The U.S. Food and Drug Administration (FDA) granted AXS-05 fast track designation in May 2017. Fast track designation helps to expedite the development and approval of medications that meet serious unmet medical needs.
How does AXS-05 work?
The first component of AXS-05, dextromethorphan, has potent effects on various neurotransmitter systems in the brain that may be involved in agitation. These include glutamate, serotonin, and norepinephrine. However, the body breaks down dextromethorphan very quickly, which can limit its effectiveness.
The second component of AXS-05, bupropion, stabilizes dextromethorphan to make it more effective. In addition, bupropion increases the availability of the neurotransmitters dopamine and norepinephrine and acts on acetylcholine, which also may play a role in agitation.
Agitation is an umbrella term that refers to feelings of restlessness, emotional distress, aggression, irritability, and a loss of social awareness.
AXS-05 in clinical trials
Axsome began a Phase 2/3 clinical trial (NCT03226522) in the summer of 2017 to investigate the effectiveness and safety of AXS-05 in treating agitation in Alzheimer’s disease patients. Researchers assigned participants randomly to receive either AXS-05 (159 participants), bupropion only (49 participants), or placebo (158 participants) for five weeks. They assessed patients’ agitation symptoms using the Cohen-Mansfield agitation inventory (CMAI.)
Following a pre-planned interim analysis in late 2018, however, enrollment in the bupropion arm ceased; those subsequently entering the study were assigned randomly to either AXS-05 or placebo.
The trial, which was expected to be completed in June 2020, concluded early due to concerns related to the COVID-19 pandemic. Top-line results demonstrated that at week five, patients in the AXS-05 group showed a significant reduction in CMAI scores compared to the placebo or bupropion groups.
Last updated: May 14, 2020
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