PH94B Nasal Spray for Anxiety Disorders
PH94B is an innovative synthetic investigational neurosteroid developed from proprietary compounds called pherines. With its novel mechanism of action, PH94B is an odorless nasal spray administered at microgram-level doses 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. Importantly, PH94B does not require systemic uptake and distribution to produce its rapid-onset anti-anxiety effects. In all clinical trials to date, PH94B’s safety profile has been excellent, with placebo-like side effects and no serious adverse events like those that are associated with the current FDA-approved treatment options.
For PH94B’s lead indication of Social Anxiety Disorder, the FDA has granted Fast Track designation for its development for the acute treatment of SAD. This is believed to be the first such designation ever granted by the FDA for a SAD drug candidate. 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.
Based on the results of Phase 2 studies, PH94B has the potential to be the first FDA-approved acute treatment of anxiety for millions who suffer from SAD worldwide. In addition, PH94B has therapeutic potential in multiple additional anxiety disorders, including, among others, adjustment disorder, postpartum anxiety, pre-procedural anxiety, post-traumatic stress disorder, panic disorder and generalized anxiety disorder.