A phase 3 trial evaluating the efficacy and safety of PH94B for the acute treatment of anxiety in adults with social anxiety disorder did not meet its primary endpoint, according to VistaGen Therapeutics.
PH94B is a first-in-class investigational pherine nasal spray. The multicenter, randomized, double-blind, placebo-controlled, parallel design PALISADE-1 study (ClinicalTrials.gov Identifier: NCT04754802) included 209 adults with social anxiety disorder.
Patients were randomly assigned to receive either PH94B or placebo as a one-time intranasal spray delivered 20 minutes before an induced public speaking challenge to relieve symptoms of anxiety.
Results showed that treatment with PH94B did not meet the primary endpoint, as measured by the change from baseline using the Subjective Units of Distress Scale, compared with placebo. The safety of PH94B was consistent with that seen in previous studies; there were no severe or serious adverse events reported.
“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,” said Shawn Singh, CEO of VistaGen. “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 [ClinicalTrials.gov Identifier: NCT05011396)] and for continued use in our ongoing phase 2 trial in adjustment disorder with anxiety [ClinicalTrials.gov Identifier: NCT04404192].”
The FDA previously granted Fast Track designation to PH94B for on-demand treatment of social anxiety disorder.
VistaGen announces topline results from PALISADE-1 phase 3 clinical trial for investigational drug PH94B. News release. VistaGen Therapeutics, Inc. Accessed July 22, 2022. https://www.businesswire.com/news/home/20220722005107/en/VistaGen-Announces-Topline-Results-from-PALISADE-1-Phase-3-Clinical-Trial-for-Investigational-Drug-PH94B