PH10 for Major Depressive Disorder (MDD)
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. Close to 800,000 people die due to suicide every year, and it is the second leading cause of death in individuals 15-29 years old. For many people, depression cannot be controlled for any length of time without treatment. Currently available FDA-approved medications available in the multi-billion-dollar global antidepressant market often fall far short of satisfying the unmet medical needs of millions suffering from the debilitating effects of depression.
While current FDA-approved antidepressants are widely used, about two-thirds of patients with MDD do not respond to their initial antidepressant treatment. Inadequate response to current antidepressants is among the key reasons MDD is one of the leading public health concerns in the United States, creating a significant unmet medical need for new agents with fundamentally different mechanisms of action.
PH10 is a first-in-class investigational neuroactive steroid administered as a nasal spray to bind locally on nasal chemosensory receptors and trigger neural responses in the hypothalamus, amygdala, prefrontal cortex and hippocampus believed to be related to depression. In a small exploratory Phase 2a study in patients with MDD, PH10 showed rapid-onset antidepressant effects, as measured by the Hamilton Depression Rating Scale (HAM-D), without psychological side effects or safety concerns.
We are preparing to advance Phase 2b development of PH10 for front-line treatment of MDD.
- World Health Organization. Preventing suicide: a global imperative. Available at: http://www.who.int/mental_health/suicideprevention/world_report_2014/en/