Major Depressive Disorder
Depression is a Global Public Health Concern
Depression is a serious medical illness and a global public health concern that can occur at any time over a person's life. While most people will experience depressed mood at some point during their lifetime, major depressive disorder (MDD) is different. MDD is the chronic, pervasive feeling of utter unhappiness and suffering, which impairs daily functioning. Symptoms of MDD include diminished pleasure in activities, changes in appetite that result in weight changes, insomnia or oversleeping, psychomotor agitation, loss of energy or increased fatigue, feelings of worthlessness or inappropriate guilt, difficulty thinking, concentrating or making decisions, and thoughts of death or suicide and attempts at suicide. Suicide is estimated to be the cause of death in up to 15% individuals with severe MDD or bipolar disorder. For many people, depression cannot be controlled for any length of time without treatment. Standard medications available in the multi-billion-dollar global antidepressant market include commonly prescribed selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) and atypical antipsychotics such as aripiprazole.
The Issues with Standard Antidepressants (SSRIs and SNRIs)
About two out of every three drug-treated patients suffering from depression do not receive adequate therapeutic benefit from their initial treatment with a standard, FDA-approved antidepressant, and the likelihood of achieving remission declines with each successive treatment attempt.
We are developing AV-101, a new generation, oral CNS prodrug candidate in Phase 2 clinical development, initially as adjunctive treatment, replacing the widespread use of atypical antipsychotics such as aripiprazole, for tens of millions of MDD patients worldwide suffering from an inadequate response to standard antidepressants. Paradigm-shifting clinical studies performed by Dr. Carlos Zarate and others at the National Institute of Mental Health (NIMH), Yale University and several other academic research centers have demonstrated that, when given intravenously, a single low dose of ketamine can produce robust and rapid antidepressant effects in MDD patients. AV-101 is functionally similar to ketamine in that both are NMDA receptor antagonists. However, AV-101 modulates NMDA receptor channel activity and ketamine blocks it. We believe that this difference in receptor activity can potentially bypass the adverse side effects that occur with ketamine.
Where AV-101 Might Fit as an Adjunctive Therapy in the Depression Treatment Algorithm