PALISADE Phase 3 Clinical Program – Social Anxiety Disorder
The PALISADE Phase 3 Program is underway to evaluate the efficacy and safety of PH94B for the acute treatment of anxiety in adults with Social Anxiety Disorder (SAD). PH94B is an odorless, rapid-onset, investigational pherine nasal spray with a unique mechanism of action, working differently than all existing therapies for SAD. There is currently no U.S. Food and Drug Administration (FDA) approved acute treatment of anxiety for adults with SAD.
PALISADE-1 is the first Phase 3 clinical trial in the PALISADE Phase 3 Program. It is a double-blind, placebo-controlled study being conducted across 15 clinical sites in the U.S., with a target of approximately 208 randomized subjects. Dr. Michael Liebowitz, a Columbia University psychiatrist, former director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, director of the Medical Research Network in New York City, and creator of the Liebowitz Social Anxiety Scale (LSAS), is serving as Principal Investigator of the trial. Topline results from PALISADE-1 are anticipated in mid-2022.
To find out more about PALISADE-1, including criteria for recruitment, please visit the ClinicalTrials.gov site here.
PALISADE-2, the second Phase 3 clinical trial in the PALISADE Phase 3 Program, is identical to PALISADE-1 in design and size and is also being conducted across approximately 15 clinical sites in the U.S.. Topline results from PALISADE-2 are anticipated in late-2022.
To find out more about PALISADE-2, including criteria for recruitment, please visit the ClinicalTrials.gov site here.
PH94B Phase 2A Program – Adjustment Disorder with Anxiety
The exploratory Phase 2A clinical trial of PH94B in Adjustment Disorder with Anxiety is a randomized, double-blind, placebo-controlled study with an enrollment target of approximately 40 adults at clinical sites in the Boston and New York City metro areas. Dr. Michael Liebowitz is serving as Principal Investigator of the trial.
To find out more about this trial, including the criteria for recruitment, please visit ClinicalTrials.gov site here.