PH94B for Social Anxiety Disorder

No longer recruiting at 2 trial locations

Overseen By Cherilyn Boller

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VistaGen Therapeutics, Inc.

Must be taking: Antidepressants, Buspirone

Must not be taking: Anticonvulsants, Mood stabilizers, Antipsychotics, Benzodiazepines

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a nasal spray called PH94B for individuals with social anxiety disorder (SAD). Participants will use the spray up to four times daily in anxiety-inducing situations. The trial aims to determine if the treatment is safe and well-tolerated over a year. Individuals with a current diagnosis of social anxiety disorder who experience it in their daily lives might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new treatment to market.

Do I have to stop taking my current medications for the trial?

You may need to stop certain medications to join the trial. Specifically, you cannot use certain psychotropic medications, anxiolytics (like benzodiazepines), or treatments for anxiety within 30 days before starting the study and during the study. However, if you are on antidepressants or buspirone, you can continue them if you've been on a stable dose for at least a month.

Is there any evidence suggesting that PH94B is likely to be safe for humans?

Research shows that PH94B, a nasal spray for social anxiety disorder, is safe for use. Studies have found that patients generally tolerate PH94B well when used as needed. These studies have reported no major safety issues, increasing confidence in its safety.

Some studies noted that patients experienced only mild side effects, if any. This suggests that PH94B can be used several times a day without significant risk. This is encouraging for those considering joining a clinical trial, as existing data supports its safety for repeated use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for social anxiety disorder, which often involve oral medications like SSRIs or benzodiazepines, PH94B is a nasal spray that provides rapid relief from acute anxiety. Researchers are excited about PH94B because it acts directly on nasal chemosensory receptors, potentially offering faster results without the systemic side effects common in oral medications. This unique delivery method allows for on-demand usage, giving individuals more control over their anxiety symptoms as they arise.

What evidence suggests that PH94B might be an effective treatment for anxiety?

Research has shown that PH94B, also known as fasedienol, holds promise as a treatment for social anxiety disorder. Studies found that people using PH94B experienced significantly less anxiety than those who took a placebo, a substance with no active medicine. This nasal spray quickly calms the body's "fight or flight" response, which often activates during stressful situations. In recent trials, many participants reported feeling much better after using PH94B. These results suggest that PH94B could be a safe and effective way to manage social anxiety. ^{6 7 8 9 10}

Who Is on the Research Team?

Jaakko Lappalainen, MD, PhD

Principal Investigator

VistaGen Therapeutics

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects who finish Palisade-1 (NCT047548020) and Palisade-2 (NCT05011396) will be in the study.

Women who might become pregnant during the study must be able to use contraception correctly and must have a negative pregnancy test before starting the study

is based on subjective judgement Social anxiety disorder is currently being diagnosed based on the judgement of a person's subjective experiences.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use PH94B nasal spray up to 4 times a day for anxiety-provoking situations over 12 months

12 months

Monthly visits from baseline to end of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PH94B

How Is the Trial Designed?

Group I: PH94B 3.2 micrograms Experimental Treatment 1 Intervention

100 microliter nasal spray to each nostril up to four times a day as needed for acute anxiety

Who Is Running the Clinical Trial?

VistaGen Therapeutics, Inc.

Lead Sponsor

Trials

12

Recruited

1,900+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24700254/

Effect of an acute intranasal aerosol dose of PH94B on ...

Conclusions: PH94B may be a novel, effective, and well-tolerated acute treatment for performance and social anxiety in women with social anxiety disorder.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05011396?term=AREA%5BBasicSearch%5D(palisade-2)&rank=1

NCT05011396 | PH94B Nasal Spray for Anxiety Induced ...

This Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute administration of 3.2 µg of PH94B to relieve ...

3.

vistagen.com

vistagen.com/pipeline/PH94B/overview

Vistagen's Innovative Treatment for Social Anxiety

In the second half of 2023, Vistagen reported positive results from its PALISADE-2 Phase 3 trial of fasedienol in adults with SAD, with the trial meeting its ...

4.

psychiatryonline.org

psychiatryonline.org/doi/10.1176/appi.ajp.2014.12101342

Effect of an Acute Intranasal Aerosol Dose of PH94B on ...

A significantly greater proportion of the PH94B group were much or very much improved from the first to the second sets of challenges compared with the placebo ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/hup.2892

Effect of fasedienol (PH94B) pherine nasal spray and ...

Results suggest that rapid onset of effects from fasedienol counteract heightened sympathetic activation and reduce symptoms of anxiety ...

6.

vistagen.com

vistagen.com/node/12846/pdf

Vistagen Presents Fasedienol (PH94B) Safety and ...

“These data advance the body of evidence supporting fasedienol's safety profile and potential to achieve overall reduction in anxiety for adults.

7.

vistagen.com

vistagen.com/static-files/dd66f568-c32f-47ca-a67f-2c4fcb09ec40

A Phase 3 Open-label Safety Trial of Fasedienol (PH94B) ...

A Phase 3 Open-label Safety Trial of Fasedienol (PH94B) Nasal Spray in the Treatment of Anxiety in Adults With Social Anxiety Disorder (SAD).

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04404192

PH94B in the Treatment of Adjustment Disorder With Anxiety

This placebo-controlled clinical study is designed to evaluate the efficacy, safety and tolerability of administration of PH94B nasal spray four times per ...

9.

empr.com

empr.com/home/news/drugs-in-the-pipeline/intranasal-fasedienol-appears-to-be-safe-effective-for-social-anxiety-disorder/

Intranasal Fasedienol Appears to Be Safe, Effective for ...

As-needed intranasal administration of fasedienol (PH94B) was found to be safe and well tolerated in patients with social anxiety disorder, according to phase ...

10.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06809179

Study Details | NCT06809179 | A Clinical Trial to Assess ...

A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With ...