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PH94B · 3 trials · 2 indications
The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt
The primary study endpoint is average peak anxiety level for public performance or social interaction events during the two 2-week double-blind treatment phases (PH94B and placebo). Subjects will be asked to self-administer double-blind PH94B or placebo 15 minutes prior to public performance or social interaction events. Following each event, they will be asked to record the maximum (peak) subjective anxiety level experienced during the event using the patient rated Subjective Units of Distress Scale (SUDS), where anxiety scores range from 0 (no anxiety) to 100 (maximum anxiety ever experienced). Within each 2-week treatment phase, all subjective anxiety ratings will be summed and divided by the number of events recorded.
Least squares mean change from baseline to Visit 6 in anxiety level as measured by the HAM-A at the end of the 4-week treatment period. The HAM-A questionnaire consists of 14 items, each scored on a 5-point scale (0="Not present", 1="Mild", 2="Moderate", 3="Severe", 4="Very severe. The HAM-A total score is calculated as the sum of the 14 individual scores, ranging from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe. Higher total scores indicate more severe disease.
| Arm | Type | Description |
|---|---|---|
| PH94B | EXPERIMENTAL | PH94B Nasal Spray - single treatment with 3.2 micrograms PH94B |
| Placebo | EXPERIMENTAL | Placebo Nasal Spray - single treatment with placebo |
| PH94B Nasal Spray | EXPERIMENTAL | Water based solution of 16 ppm PH94B. Each nasal spray delivers .8 micrograms PH94B in 50 microliters |
| Placebo Nasal Spray | PLACEBO_COMPARATOR | Water based solution, each nasal spray delivers 50 microliters of droplets. |
| Name | Type | Description |
|---|---|---|
| PH94B Nasal Spray | DRUG | Nasal spray delivered 20 minutes before the public speaking stressor |
| Placebo Nasal Spray | DRUG | Nasal spray delivered 20 minutes before the public speaking stressor |
| PH94B | DRUG | PH94B is self-administered intranasally as needed or as necessary, no more than four doses per day for male and female subjects. Each spray delivers 50 µL (0.8 µg PH94B). Dosing is sex-specific: * Males: two (2) sprays (100 µL) are to be administered to each nostril, for a total dose of 3.2 µg * Females: one (1) spray (50 µL) is to be administered to each nostril, for a total dose of 1.6 µg |
| Placebo | OTHER | Placebo is self-administered intranasally as needed or as necessary, no more than four doses per day for male and female subjects. Each spray delivers 50 µL (0.8 µg Placebo). Dosing is sex-specific: * Males: two (2) sprays (100 µL) are to be administered to each nostril, for a total dose of 3.2 µg * Females: one (1) spray (50 µL) is to be administered to each nostril, for a total dose of 1.6 µg |
Inclusion Criteria: 1. Written informed consent provided prior to conducting any study-specific assessment. 2. Male or female adult, 18 through 65 years of age, inclusive. 3. Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, as confirmed ...
PH94B is an investigational small molecule being developed for the acute treatment of Social Anxiety Disorder and for Adjustment Disorder With Anxious Mood. It is administered as a nasal spray. The drug is currently in clinical development and has not been approved by the FDA.
PH94B is being developed by Vistagen Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol VTGN. The company is conducting clinical trials of PH94B in the United States for psychiatric indications.
PH94B is in Phase 2 and Phase 3 clinical trials. Two Phase 3 trials have been completed for Social Anxiety Disorder, and one Phase 2 trial has been completed for Adjustment Disorder With Anxious Mood. The drug remains investigational and is not FDA approved.
PH94B has completed three clinical trials. NCT02622958 was a Phase 3 feasibility study in 23 patients with Social Anxiety Disorder. NCT04754802 was a Phase 3 trial in 224 patients with Social Anxiety Disorder induced by a public speaking challenge. NCT04404192 was a Phase 2 trial in 41 patients with Adjustment Disorder With Anxious Mood.
PH94B is not FDA approved. It is an investigational drug that has completed Phase 2 and Phase 3 clinical trials for Social Anxiety Disorder and Adjustment Disorder With Anxious Mood. All trials are completed, but the drug remains in clinical development and has not received regulatory approval.
PH94B is a distinct investigational nasal spray being developed by Vistagen Therapeutics. It is not the same as other marketed anxiety medications. The drug is being studied for acute treatment of Social Anxiety Disorder and for Adjustment Disorder With Anxious Mood, and it has no alternative names listed in clinical trial records.