PH94B for Social Anxiety Disorder

This trial tests the safety of a nasal spray called PH94B for individuals with social anxiety disorder (SAD). Participants will use the spray up to four times daily in anxiety-inducing situations. The trial aims to determine if the treatment is safe and well-tolerated over a year. Individuals with a current diagnosis of social anxiety disorder who experience it in their daily lives might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new treatment to market.

You may need to stop certain medications to join the trial. Specifically, you cannot use certain psychotropic medications, anxiolytics (like benzodiazepines), or treatments for anxiety within 30 days before starting the study and during the study. However, if you are on antidepressants or buspirone, you can continue them if you've been on a stable dose for at least a month.

Research shows that PH94B, a nasal spray for social anxiety disorder, is safe for use. Studies have found that patients generally tolerate PH94B well when used as needed. These studies have reported no major safety issues, increasing confidence in its safety.

Unlike traditional treatments for social anxiety disorder, which often involve oral medications like SSRIs or benzodiazepines, PH94B is a nasal spray that provides rapid relief from acute anxiety. Researchers are excited about PH94B because it acts directly on nasal chemosensory receptors, potentially offering faster results without the systemic side effects common in oral medications. This unique delivery method allows for on-demand usage, giving individuals more control over their anxiety symptoms as they arise.

Research has shown that PH94B, also known as fasedienol, holds promise as a treatment for social anxiety disorder. Studies found that people using PH94B experienced significantly less anxiety than those who took a placebo, a substance with no active medicine. This nasal spray quickly calms the body's "fight or flight" response, which often activates during stressful situations. In recent trials, many participants reported feeling much better after using PH94B. These results suggest that PH94B could be a safe and effective way to manage social anxiety.⁶⁷⁸⁹¹⁰