Michael Liebowitz, MD: The Value of Fasedienol

An investigative nasal spray therapy is showing high potential for the treatment of social anxiety disorder (SAD)—a mental health condition currently without any drugs indicated for use by the US Food and Drug Administration (FDA) and one historically challenged to be adequately defined and managed by care givers.

What’s more, the would-be drug is showing indications in clinical trial that it may provide long-term solutions for patients averse to anxiety-inducing scenarios.

In the second segment of an interview with HCPLive, SAD pioneer Michael Liebowitz, MD, director and founder of the Anxiety Disorders Clinic at New York State Psychiatric Institute, discussed the key characteristics of Vistagen’s fasedienol as its currently understood from phase 2 analyses. Among the primary benefits of fasedienol are its observed consistency of benefit and allowance of as-needed use. As Liebowitz noted, patients who once had to commit themselves to 12-week selective serontonin reuptake inhibitor (SSRI) regimens or even longer-term cognitive behavioral therapy (CBT) are able to acutely manage their SAD.

“It can be used in any given event, any situation—you take it 10-15 minutes before the event, and if it goes too long, maybe you step aside and give yourself a second boost,” Liebowitz said.

Among the most important clinical impacts of fasedienol include an “immediate relief or removal of dread” in anxiety-inducing social setting and its ameriolating effect on the overall SAD condition.

“Huge benefit—I mean, people abandon careers over these things,” Liebowitz noted. “ If you think about it going forward, you have it whenever you need it, and that essentially can almost remove the condition.”

Additionally, Liebowitz said crossover phase 2 trial data showed patients who switched from the treatment to placebo did not lose their benefit experienced from the drug, implying a potentially sustained benefit—if not an achieved confidence in patients with SAD who were able to experience anxiety-inducing events without the feel of anxiety.

“In the next pursuits of clinical research, investigators have 2 or 3 imperatives: continue its development toward FDA decision, demonstrate its continued safety, and answer scientific questions regarding duration of benefit and differentiation of patient outcomes,” Liebowitz said.