VistaGen Therapeutics said that the PALISADE-1 Phase 3 clinical trial of PH94B aloradine nasal spray for the treatment of anxiety in social anxiety disorder failed to meet its primary endpoint. The company announced the initiation of the PALISADE-1 trial in May 2021, and a second Phase 3 trial, PALISADE-2, got underway in September 2021. According to VistaGen, “the tolerability profile of PH94B in PALISADE-1 was favorable and consistent with previously reported results from all other clinical trials” with no reports of severe or serious adverse events.
VistaGen acquired the rights to PH94B from Pherin Pharmaceuticals in September 2018. Pherin had previously conducted a Phase 2 trial of PH94B from 2008 to 2011 and a small Phase 3 feasibility study of the nasal spray in 2014-2015. In 2019, PH94B for the treatment of social anxiety disorder received Fast Track designation from the FDA. VistaGen currently has a Phase 2a study of PH94B in people with adjustment disorder underway.
VistaGen CEO Shawn Singh commented, “The demand for new treatment options for anxiety disorders is large and growing. While the results of PALISADE-1 are not consistent with prior positive results from Phase 2 trials of PH94B in social anxiety disorder, we remain committed to transforming the treatment landscape for those living with anxiety, depression, and other central nervous system disorders. As part of this commitment, our team will continue to pursue PH94B’s potential as a new treatment option for multiple anxiety disorders — including for both acute treatment for social anxiety disorder in our ongoing PALISADE-2 Phase 3 trial and for continued use in our ongoing Phase 2 trial in adjustment disorder with anxiety. We would like to thank the patients and investigators for their participation in the trial, and we will continue to evaluate the detailed data from PALISADE-1 as we move forward with our ongoing trials.”
Read the VistaGen Therapeutics press release.
