AXS-05 is a medication being developed by Axsome Therapeutics for the treatment of agitation symptoms in patients with Alzheimer’s disease. The medication combines two compounds: bupropion and dextromethorphan.

While the most recognized symptoms of Alzheimer’s disease are memory loss and cognitive decline, many patients also experience neuropsychiatric symptoms. Up to 50 percent of patients experience agitation, which includes emotional distress, aggression, irritability, and disinhibition. Agitation is unpleasant for the patient, stressful for caregivers, and may lead to earlier placement in nursing home facilities.

When severe, agitation symptoms are typically treated with antidepressant or antipsychotic medications. There is currently no medication approved by the U.S. Food and Drug Administration (FDA) specifically for the treatment of agitation in Alzheimer’s disease.

In May of 2017, Axsome Therapeutics was granted fast track designation from the FDA for AXS-05. Fast track designation helps to expedite the development and approval of medications that meet serious unmet medical needs.

How AXS-05 works

The first component of AXS-05, dextromethorphan, has potent effects on various neurotransmitter systems in the brain (signaling molecules used by the nerve cells to communicate with each other) that may be involved in agitation. These include glutamate, serotonin, and norepinephrine. However, dextromethorphan is broken down very quickly by the body, 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, another neurotransmitter, which may also be involved in agitation.

AXS-05 in clinical trials

In the summer of 2017, Axsome Therapeutics began a Phase 2/3 clinical trial (NCT03226522) to investigate the effectiveness and safety of AXS-05 in the treatment of agitation in Alzheimer’s disease patients. The trial is called ADVANCE-1. It is currently recruiting participants, ages of 65 to 90, with diagnoses of probable Alzheimer’s and clinically significant agitation.

Participants will be treated with AXS-05, bupropion, or placebo tablets for five weeks and their agitation symptoms will be assessed with the Cohen-Mansfield agitation inventory (CMAI.) The trial is expected to be completed in September 2019.

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