The product PH94B nasal spray introduced by Ai Mai Medical for social anxiety disorder is approved for clinical use

On January 7, according to CDE's official website, the product PH94B nasal spray introduced by Ai Mai Medical was approved for clinical use, and the indication is anxiety symptoms of social anxiety disorder
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PH94B is a potential "first-in-class", fast-acting neurosteroid candidate under development by VistaGen, which has entered a Phase 3 clinical study globally for the treatment of social anxiety disorder (SAD)
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Aimmed was incubated by Cambridge Capital, which owns the development and commercialization rights of PH94B in Greater China, South Korea and Southeast Asia

Publicly available information indicates that PH94B is a potential "first-in-class", odorless, fast-acting (within about 15 minutes) synthetic neurosteroid nasal spray with the potential to treat a variety of anxiety-related disorders
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In December 2019, the US FDA granted Fast Track designation to PH94B for on-demand treatment of social anxiety disorder

It is reported that PH94B is designed to be administered intranasally in microgram doses, which is fundamentally different from all current anti-anxiety drugs, including benzodiazepines
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It is unique in that it activates peripheral nasal chemosensory neurons, triggering neural circuits in the brain that inhibit fear and anxiety, rather than binding to neuronal receptors in the central nervous system (CNS), thereby limiting the transport of molecules to the circulatory system and Minimize potential systemic exposure

Social anxiety disorder is a health problem that has received much attention
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According to the National Institutes of Health (NIH), social anxiety disorder is the third most common mental disorder after depression and substance abuse

Currently, SAD is typically treated long-term with certain regulatory-approved antidepressants, which are slow-acting (weeks) and have limited therapeutic benefit, while antidepressants and off-label benzodiazepines have been known side effects and safety concerns
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Therefore, clinically, patients have obvious needs for safe and effective new drugs

Reference materials: CDE official website, WuXi AppTec, etc.