You might soon be able to spray away your anxiety.
Vistagen, a clinical-stage biopharmaceutical company that targets treatment for central nervous system (CNS) disorders, last week announced positive Phase 3 trial results in evaluating the efficacy of fasedienol (PH948) nasal spray for adults with social anxiety disorder (SAD).
According to Vistagen, the drug demonstrated a significant improvement in clinically assessed study subjects over those who received a placebo, and was well tolerated and safe.
"We are thrilled that these compelling top-line results from the Phase 3 PALISADE-2 trial confirm what was seen in the Phase 2 studies in social anxiety disorder and highlight the potential for fasedienol, with its novel and unique proposed mechanism of action, to transform what is possible for more than 25 million people living with social anxiety in the U.S. and millions more affected worldwide," said Shawn Singh, CEO of Vistagen.
"As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas. At the head of that class, fasedienol's potential, as demonstrated in this Phase 3 trial, sets the stage for the first fundamentally new class of medicine for individuals living with SAD in more than 20 years."
The trial showed that fasedienol slashed anxiety symptoms during an anxiety-provoking situation in a single dose, noted Dr. Michael R. Liebowitz, innovator of the Liebowitz Social Anxiety Scale (LSAS), and the director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute.
"Fasedienol could be an optimal treatment for social anxiety patients given the ability to be used acutely to reduce anxiety while helping to reduce SAD over time," Liebowitz said.
According Vistagen, the nasal spray was well tolerated by study subjects, and any adverse events reported were mild to moderate. A total of 141 patients were enrolled in the U.S multi-center trial who had a diagnosis of SAD and demonstrated marked social anxiety at enrollment, with a baseline score on the LSAS of at least 70.
Vistagen plans to present the actual data of the Phase 3 trial at future scientific meetings.
The intranasal drug is administered in low microgram doses and works differently than currently approved anti-anxiety drugs such as SSRIs and SNRIs as well as benzodiazepines prescribed off-label. It works by regulating the olfactory-amygdala neural circuits of fear and anxiety, the Psychiatric Times noted.
"A future phase 3 study involving multiple administrations of over several weeks on a patient-tailored, as-needed basis will build upon the body of evidence now demonstrated in PALISADE-2 and multiple Phase 2 studies," Liebowitz said.