VistaGen Therapeutics is one step closer to launching its nasal spray for social anxiety after the FDA said it does not need an additional study testing the drug's potential to be abused.
The wave-through by regulators, which VistaGen reported Thursday, is welcome news for the biotech as it advances its nasal spray, PH94B, through two phase 3 trials for social anxiety disorder (SAD). The FDA told VistaGen that clinical and nonclinical data on the candidate show no abuse potential—and as of now, the biotech won’t need an additional human study to prove this.
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