Vistagen said that a Phase 3 open label safety study of fasedienol (PH94B, aloradine) nasal spray for the treatment of social anxiety disorder (SAD) found that up to 4 daily doses of 3.2 µg was well-tolerated, with no new safety findings. The company said that on the secondary endpoint of change from baseline on the Liebowitz Social Anxiety Scale (LSAS), “Analysis of the final data set demonstrates clinically meaningful functional improvement, as measured by the LSAS, and total LSAS scores continued to decline in consecutive months during the study.”
According to the Vistagen press release, “The study was closed early due to business reasons.” On clinicaltrials.gov, the recruitment status for the trial is listed as “Terminated (Study stopped by sponsor due to the completion of the PALISADE-1 study and the pausing of the PALISADE-2 study from which PH94B-CL030 subjects were being enrolled)” and the completion date is listed as September 23, 2022.
In July 2022, Vistagen announced that the Phase 3 PALISADE-1 trial of PH94B had failed to meet its primary endpoint but said that tolerability data were “favorable.” The company paused a second Phase 3 study at that time but announced that it was re-starting the PALISADE-2 trial in September 2022.
Vistagen CEO Shawn Singh said, “The safety profile and potential for fasedienol to achieve overall reduction in symptoms of SAD and improvement in severity of the disorder, as measured by the LSAS, have now been demonstrated in a placebo-controlled Phase 2 study after two weeks of use, as well as in this open-label study over a period of one month and beyond. We believe these data suggest that studies involving multiple administrations of fasedienol over time, on an as-needed basis at moments when subjects experience real-life, socially stressful situations, most accurately demonstrate the safety and efficacy potential of fasedienol in patients with SAD and reflect the way we believe fasedienol would be used by SAD patients, if approved.”
Read the Vistagen press release.
