The symptoms of depression can be complex and vary between people. If you're depressed, you feel sad, hopeless and lose interest in things you used to enjoy, and this state persists for at least two weeks.
Sixteen million American adults will suffer from clinical depression in any given year. This represents almost 7% of U.S. adults (NIH).
Depression is the leading cause of disability worldwide (WHO). Depression is a key risk factor for suicide, and also for cancer, heart diseases, and obesity. Depression shortens life-expectancy by an average of about 10 years.
First line antidepressants are the selective serotonin reuptake inhibitors (SSRIs, e.g. Prozac) and serotonin norepinephrine reuptake inhibitors (SNRIs, e.g. Effexor). But SSRIs and SNRIs only adequately treat one-third of depression patients (NIH). Psychotherapy is right for some patients, but is no more effective than antidepressants. Depression remains a massive unmet medical need.
The only drug class recognized by the FDA to confer additional antidepressant efficacy is the atypical antipsychotics (e.g. Abilify). Atypical antipsychotics are administered adjunctive to ongoing SSRI/SNRI therapy. However, only one in nine depression patients respond adequately to adjunctive atypical antipsychotics. Safety and tolerability, as well as stigma, remains a concerns with atypical antipsychotics.
EVX-101 is a novel adjunctive antidepressant that will enhance SSRI or SNRI antidepressant efficacy by increasing natural brain synthesis of serotonin. This is a novel therapeutic mechanisms, which differs fundamentally from the antipsychotics. It is expected that the safety of EVX-101 will be superior to the antipsychotics. EVX-101 will offer a new and safer option to depression patients not responding adequately to available therapies.