A New Therapeutic Approach

How It Works
The components of AXS-05, DM and bupropion, each target different CNS receptor systems. Combining the distinct and independent mechanisms of action of these two compounds may be useful in the treatment of CNS disorders. However DM is rapidly metabolized in humans. As a result, it is difficult to attain potential therapeutic blood levels of DM when it is dosed as a single agent. In addition to its activity at CNS receptors, the bupropion component of AXS 05 serves as a novel drug delivery method to inhibit DM metabolism and thereby increase its blood concentrations.

Clinical and Regulatory

AXS-05 is currently being developed for the treatment of Major Depressive Disorder (MDD), Alzheimer’s Disease agitation, and Smoking Cessation.  We have received breakthrough therapy designation from the FDA for both Major Depressive Disorder and Alzheimer’s Disease agitation.  We intend to seek FDA approval for AXS-05 utilizing the 505(b)(2) regulatory development pathway. An NDA for MDD is planned.

Product Pipeline


Patients diagnosed with major depressive disorder (MDD) are defined as having TRD if they have failed two or more antidepressant therapies. There are approximately 5.7 million estimated patients with TRD in the United States.

More about Depression

Alzheimer’s Disease Agitation
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder that manifests initially as forgetfulness advancing to severe cognitive impairment and memory loss. It is a common form of dementia and afflicts an estimated 5 million individuals in the United States, a number that is anticipated to increase to approximately 14 million by 2050. In addition to cognitive decline, individuals diagnosed with AD typically experience behavioral and psychological symptoms including agitation which is reported in approximately 45% of patients. Agitation is characterized by emotional distress, aggressive behaviors, disruptive irritability, and disinhibition.

More about AD

Key Opinion Leader Presentations

Psychopharmacology of AXS-05: Potential Clinical Implications, Dr Stephen Stahl
April, 2018

Pharmacodynamic Synergy
The modulation of DM allows it to reach therapeutic plasma levels allowing DM to act on targeted CNS receptor systems. Combining the distinct and independent mechanisms of action of these two compounds with AXS-05 may be useful in the treatment of a variety of CNS disorders.