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 and, at this time, based on studies completed to date, a human abuse potential (HAP) study with PH94B is not required
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- VistaGen Therapeutics, Inc. (NASDAQ:VTGN), a late clinical-stage, central nervous system (CNS) focused biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other CNS disorders, announced today a key regulatory update on its PALISADE Phase 3 Program for PH94B for the acute treatment of anxiety in adults with social anxiety disorder (SAD).
The U.S. Food and Drug Administration (FDA) recently indicated the following regarding VistaGen’s late-stage development of PH94B for the acute treatment of SAD:
- Nonclinical and clinical data in studies completed to date provide no signal of abuse potential;
- Receptor binding data do not show that PH94B has affinity for abuse-related sites, such as dopamine, opiate or GABA;
- Intravenous administration of PH94B to animals provides no overt behavioral responses;
- No additional nonclinical studies are needed to evaluate the abuse potential of PH94B; and
- While the need for a human abuse potential (HAP) study with PH94B may be revisited by the FDA upon completion of current and planned clinical trials, because studies completed to date provide no signal of abuse potential, at this time, conducting a HAP study of PH94B is not necessary.
“There are more than 25 million people in the United States suffering from social anxiety disorder, or SAD, and many of them do not have adequate treatment options available,” said Shawn Singh, Chief Executive Officer of VistaGen. “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. This clear and timely feedback from the FDA further emboldens our team and our steadfast efforts to advance PH94B on behalf of the millions of people struggling with SAD."