The Food and Drug Administration (FDA) has granted Fast Track designation to PH94B (aloradine; VistaGen Therapeutics), a central nervous system (CNS) neuroactive nasal spray for the on-demand treatment of social anxiety disorder.

Fast Track status will allow for expedited review of the investigational treatment. In a phase 2 trial (n=91), intranasal administration of PH94B, a synthetic neuroactive steroid, 15 minutes prior to a simulated public speaking and social interaction challenge was found to significantly reduce anxiety levels in patients with social anxiety disorder. In addition, data from a pilot phase 3 crossover study in 22 patients demonstrated a significantly greater reduction in average peak Subjective Units of Distress scores (primary end point) with PH94B compared with placebo. 

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“With a high global prevalence of anxiety disorders, including SAD, and alarming increases in dependency, addiction and even deaths associated with misuse of benzodiazepines, the urgency for a new non-addictive, non-sedating, fast-acting, as-needed treatment for SAD and other anxiety disorders is more important now than ever before,” said Shawn Singh, Chief Executive Officer of VistaGen. “Based on clinical studies to date, PH94B, at non-systemic microgram doses, has strong potential to fill the large current treatment gap.”

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Vistagen is currently preparing for phase 3 development of PH94B for social anxiety disorder; the Company believes the treatment may also have potential for other anxiety disorders such as peripartum anxiety, pre/postoperative anxiety, post-traumatic stress disorder, panic disorder, and generalized anxiety disorder.

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This article originally appeared on MPR