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
AXS-05 is currently in a Phase 3 trial for the treatment of treatment resistant depression (TRD). An Investigational New Drug Application (IND) for a Phase 2/3 trial of AXS-05 for the treatment of agitation in patients with Alzheimer’s disease has received FDA clearance.

Product Pipeline

Indications

Treatment Resistant Depression (TRD)
Patients diagnosed with major depressive disorder (MDD) are defined as having TRD if they have failed two or more antidepressant therapies. There are approximately 3 million estimated patients with TRD in the United States.

More about TRD

Agitation in Patient’s with Alzheimer’s Disease (AD)
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 as many as 40% of patients. Agitation is characterized by emotional distress, aggressive behaviors, disruptive irritability, and disinhibition.

More about AD