TextPharmaceutical Guanlan
Recently, the website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that a new class 1 drug named PH94B nasal spray has obtained an implied license for clinical trials and is intended to be developed for: adult social anxiety disorder (SAD) anxiety symptoms
.
According to public information, PH94B is a potential "first-in-class", fast-acting neurosteroid candidate drug under development by VistaGen, and Ai Mai Medical owns its development and commercialization rights in Greater China, South Korea and Southeast Asia
.
At present, the product has entered the phase 3 clinical research stage for the treatment of SAD globally
.
Screenshot source: CDE official website
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
.
In December 2019, the US FDA granted Fast Track designation to PH94B for on-demand treatment of social anxiety disorder
.
According to VistaGen's press release at the time, this was the FDA's first Fast Track designation for a SAD drug candidate
.
It is reported that PH94B is intended for intranasal administration in microgram doses
.
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
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Therefore, PH94B has a fast-acting pharmacological profile and a favorable safety profile, and does not require systemic absorption and distribution to produce a fast-acting anxiolytic effect
.
Previously, PH94B has achieved positive results in Phase 2 clinical studies
.
The drug candidate rapidly reduced (within 15 minutes) anxiety symptoms in subjects in response to the public speaking challenge (p=0.
002) and the social interaction challenge (p=0.
009)
.
Subsequently, VistaGen launched Phase 3 trials PALISADE-1 and PALISADE-2 of PH94B for the acute treatment of anxiety disorders in adults
.
(Original abridged)
