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2023-08-10| Trials & Approvals

Vistagen’s Positive Phase 3 Results for Social Anxiety Treatment

by GeneOnline
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On August 7, Vistagen announced positive outcomes for the Phase 3 trial of their nasal spray, Fasedienol, for adults with social anxiety disorder (SAD). The phase 3 PALISADE-2 trial met its endpoints, and its results indicate that it has the potential to reduce anxiety. Faseldienol has the capacity to emerge as a treatment option for individuals with social anxiety. 

Related Article: VistaGen’s Antidepressant Nasal Spray Succeeds Phase 2a Trial

Fasedeinol’s Positive Outcomes in Phase 3 Trial

Vistagen is a clinical-stage biopharmaceutical company whose goal is to revolutionize the treatment of people suffering from anxiety, depression, and other central nervous system disorders. They aim to accomplish this through faster-acting treatments like their nasal spray for the treatment of SAD. Currently, more than 25 million people in the US alone suffer from Social Anxiety Disorder. SAD is a type of anxiety disorder in which a person feels intense symptoms of anxiety and fear in social situations. For people suffering from SAD, common day-to-day activities become a burden and can oftentimes be overwhelming. 

The disorder is normally treated with antidepressants and benzodiazepines. The former takes several weeks for its effects to be seen, and the latter isn’t approved as a treatment for SAD by the FDA. Furthermore, both of these treatments have undesirable side effects and safety concerns that make them unattractive. Fasedienol presents an alternative with a faster onset of action as well as a more favorable safety profile. The Chief Executive Officer of Vistagen, Shawn Singh, said, “We are thrilled that these compelling top-line results from the Phase 3 PALISADE-2 trial confirm what was seen in the Phase 2 studies in social anxiety disorder and highlight the potential for fasedienol, with its novel and unique proposed mechanism of action, to transform what is possible for more than 25 million people living with social anxiety in the U.S. and millions more affected worldwide.” 

Treating Social Anxiety Disorder 

Fasedienol is Vistagen’s candidate for the treatment of Social Anxiety Disorder. It is a nasal spray that utilizes a new mechanism of action that regulates the neural circuits of anxiety and fear.  The treatment works by activating receptors in the peripheral nasal chemosensory neurons, which are then connected to other neurons involved in the pathophysiology of Social Anxiety Disorder. It was designed to be administered intranasally in microgram doses. 

Vistagen’s phase 3 study, PALISADE-2, is a double-blind, placebo-controlled trial in adults with SAD. It was designed to evaluate the drug’s safety and efficacy when administered during a simulated anxiety-inducing event. Its efficacy was measured using patients’ reported Subjective Units of Distress Scale (SUDS), which measures the intensity of distress in people with anxiety. Despite the positive results, Vistagen decided to close the study due to its expense and methodological challenges.

So far, Fasedienol has shown promising results in its phase 3 trial. Additional analysis of the data for the PALISADE-2 trial is still ongoing, and the company plans to present its findings at future scientific meetings. The nasal spray differs from the current drugs on the market used for treating SAD in that it is much faster-acting and has fewer side effects. Vistagen is pioneering the treatment of anxiety and could potentially change the treatment of Social Anxiety Disorder.

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