PH94B Nasal Spray for Anxiety Disorders

PH94B Nasal Spray for Anxiety Disorders

PH94B is a first-in-class synthetic investigational neurosteroid developed from proprietary compounds called pherines. With its novel mechanism of action (MOA), PH94B is a nasal spray administered at microgram-level doses and designed to achieve rapid-onset anti-anxiety, or anxiolytic, effects. The pharmacological activity of PH94B is fundamentally differentiated from that of all FDA-approved anti-anxiety drugs, including all antidepressants approved by the U.S. Food and Drug Administration (FDA) for the treatment of Social Anxiety Disorder (SAD), as well as all benzodiazepines and beta blockers prescribed on an off-label basis.

The MOA for PH94B does not involve systemic uptake, direct activation of GABA-A receptors in the brain, or binding to neuronal receptors in the CNS. Rather, when administered intranasally, PH94B binds to chemosensory neurons in the nose that activate neural circuits involving olfactory bulb neurons and the limbic amygdala, a region in the brain that is involved in the pathophysiology of SAD and potentially other anxiety and mood disorders.

In an acute treatment manner analogous to the use of a rescue inhaler before a predictable asthma attack or a migraine drug before onset of a migraine episode, PH94B has the potential to be used as needed by a person with SAD before an anxiety-provoking stressor.

We are currently evaluating PH94B for the potential treatment of multiple anxiety disorders, including for adults with SAD and for adults experiencing Adjustment Disorder with Anxiety (AjDA). Both pre-clinical and Phase 2 clinical data to date suggest that PH94B has the potential to achieve rapid-onset anti-anxiety effects without systemic uptake or transport into the brain, reducing the risk of side effects and other safety concerns such as abuse potential associated with certain other pharmaceuticals that act directly on the CNS and are sometimes prescribed for anxiety disorders.

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