VTGN - VistaGen says FDA found no signal of abuse potential for its nasal spray PH94B for anxiety
VistaGen Therapeutics (NASDAQ:VTGN) on Thursday said the U.S. Food and Drug Administration (FDA) agreed that the company's nasal spray PH94B for the acute treatment of social anxiety disorder (SAD) did not show any abuse potential. The FDA agreed that data from nonclinical and clinical studies of PH94B completed to date provide no signal of abuse potential. The FDA also agreed that additional nonclinical studies are not necessary to evaluate the abuse potential of PH94B. The regulator said that, at this time, based on studies completed to date, a human abuse potential study with PH94B is not needed. “As PH94B continues to progress through our Phase 3 development program in SAD, we are encouraged by our consensus view with the FDA on the important dimension of abuse liability," said VTGN CEO Shawn Singh. VTGN stock -2.1% to $1.39 in morning trade.
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VistaGen says FDA found no signal of abuse potential for its nasal spray PH94B for anxiety