As-needed intranasal administration of fasedienol (PH94B) was found to be safe and well tolerated in patients with social anxiety disorder, according to phase 3 trial results.
Fasedienol is a first-in-class, rapid-onset investigational pherine nasal spray. The open-label study (ClinicalTrials.gov Identifier: NCT05030350) evaluated the safety and tolerability of multiple, as-needed doses of fasedienol in adults with social anxiety disorder. Study participants (N=481) administered the intranasal therapy up to 4 times per day when they encountered anxiety-provoking situations in daily life.
An evaluation of safety and tolerability showed that 54.9% of patients reported mild or moderate treatment emergent adverse events, with headache being the most common side effect (17%). Compared with previous data, no new safety findings or trends were identified in the study.
Findings from an exploratory efficacy analysis showed that treatment with fasedienol led to clinically meaningful reductions in fear, anxiety, and avoidance of anxiety-provoking social and performance situations in daily life, as measured by the Liebowitz Social Anxiety Scale (LSAS). The LSAS is an assessment of symptomatology of social anxiety disorder severity.
At months 1, 2, and 3, 36%, 44%, and 55%, of patients experienced a 20-point or greater reduction on the LSAS, respectively. Those who continued in the study saw improvements each month through 9 months.
“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 2 weeks of use, as well as in this open-label study over a period of 1 month and beyond,” said Shawn Singh, Chief Executive Officer of Vistagen. “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.”
The Food and Drug Administration previously granted Fast Track designation to fasedienol for on-demand treatment of social anxiety disorder.
This article originally appeared on MPR
Vistagen announces positive data in fasedienol (PH94B) phase 3 open-label study in adults with social anxiety disorder. News release. Vistagen. March 22, 2023. https://www.businesswire.com/news/home/20230322005351/en/Vistagen-Announces-Positive-Data-in-Fasedienol-PH94B-Phase-3-Open-Label-Study-in-Adults-with-Social-Anxiety-Disorder.