On January 7, the NmPA approved a clinical trial application for VistaGen Therapeutics' PH94B nasal spray for the treatment of anxiety symptoms of adult social anxiety disorder (SAD). As early as December 2019, PH94B was granted fast-track qualification by the U.S. FDA for on-demand treatment of SAD. VistaGen has said it is the first drug in the SAD candidate to qualify for fda fast-track qualification.
What is Social Anxiety Disorder?
Social anxiety disorder is a mental illness that feels intense fear or apprehension about any social or public situation. Patients have a significant and persistent fear of social or performance situations in front of strangers or where they may be carefully observed by others, fearing that their behavior or nervous performance will cause humiliation or embarrassment. Some patients find it difficult to attend a party, make a phone call, go shopping at a store, or ask an authority person.
Causes of social anxiety disorder
Physiological causes. Experts said: social phobia may be caused by the imbalance of "serotonin" in the human body, which is responsible for transmitting information to brain nerve cells, and too much or too little "serotonin" can cause people to fear emotions;
Psychological reasons. People with social phobia are generally people with too much self-esteem, who are afraid of being rejected, or who do not have confidence in their appearance;
Family reasons. Repressed personality from an early age, or lack of attention to the development of social skills in family education, or excessive family relocation;
Social reasons. The harsh social environment has led to more setbacks in life and interaction.
Way of thinking. Incorrect ways of thinking create social phobias, such as excessive self-reflection after an overly perfectionist is hit. Every person with social phobia should be interested in the "self", that is, the self, the ego, the superego... Be fully aware.
Advantages of PH94B
PH94B is a potential "first-in-class" anabolic neurosteroid nasal spray that is tasteless, fast-acting, safe, and has the potential to treat a variety of anxiety-related conditions. Ph94B is very different from benzodiazepines such as diazepam, which is intranasal administration that triggers neural circuits in the brain that inhibit fear and anxiety by activating peripheral nasal chemical sensing neurons. Therefore, it does not need to achieve a systemic distribution, and also avoids systemic exposure, with faster natural onset and higher safety.
brief summary
SAD is a health problem that is currently of great concern, and it is the most common mental illness in addition to depression and substance abuse. People with SAD experience intense, persistent symptoms of anxiety or fear in certain social situations, such as meeting new people, dating, interviews, etc. The existing therapeutic drugs for SAD have slow onset of action and low safety, so there is a clear demand for safe and effective new drugs in clinical patients.
PH94B is currently in Phase III clinical phase. It was a randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of PH94B in the treatment of ADULT SAD. Clinical trials are expected to demonstrate that PH94B can benefit SAD patients and address the clinical needs of SAD.
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