VistaGen Therapeutics has announced the successful completion of Phase 3 safety studies for its social anxiety disorder nasal spray. The results of the study showed that the nasal spray is safe and well-tolerated in all patients.
The company’s PH94B nasal spray is designed to provide rapid relief to patients experiencing social anxiety disorder by targeting the amygdala, a region of the brain responsible for processing fear and anxiety. Unlike current treatment options such as benzodiazepines and selective serotonin reuptake inhibitors (SSRIs), PH94B is fast-acting and does not cause systemic side effects.
Social anxiety disorder affects approximately 15 million adults in the United States, with symptoms including fear, anxiety, and self-consciousness in social situations. Despite the availability of treatment options, many patients continue to experience significant anxiety symptoms, indicating a need for more effective and targeted therapies.
The Phase 3 safety study enrolled 232 patients with social anxiety disorder, who were randomized to receive either PH94B nasal spray or placebo. The study evaluated the safety and tolerability of PH94B over a period of four weeks. VistaGen reported that there were no serious adverse events or treatment-related withdrawals, indicating that the nasal spray is safe and well-tolerated in all patients.
VistaGen’s CEO, Shawn Singh, noted that the successful completion of the Phase 3 safety study is a significant milestone for the company, as it brings them closer to providing a novel treatment option for patients with social anxiety disorder. The company plans to initiate a Phase 3 efficacy study later this year to evaluate the effectiveness of PH94B in reducing anxiety symptoms in patients with social anxiety disorder.
If the Phase 3 efficacy study is successful, PH94B has the potential to become the first fast-acting, non-systemic treatment for social anxiety disorder. VistaGen is also exploring the potential of PH94B in other anxiety-related disorders, including post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD).
VistaGen Therapeutics has announced the successful completion of Phase 3 safety studies for its PH94B nasal spray, designed to provide rapid relief for patients experiencing social anxiety disorder. The results of the study showed that the nasal spray is safe and well-tolerated in all patients. The successful completion of the Phase 3 safety study is a significant milestone for VistaGen as it brings them closer to providing a novel treatment option for patients with social anxiety disorder. The company plans to initiate a Phase 3 efficacy study later this year to evaluate the effectiveness of PH94B in reducing anxiety symptoms in patients with social anxiety disorder. If the efficacy study is successful, PH94B has the potential to become the first fast-acting, non-systemic treatment for social anxiety disorder, with potential applications in other anxiety-related disorders such as PTSD and GAD.
In addition to its fast-acting and non-systemic properties, PH94B has the potential to be more accessible and convenient for patients who may not want to take medication orally or may experience side effects from current treatments. The success of this study underscores the importance of continued research and development in mental health, particularly in the area of personalized, targeted therapies.
