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Also known as PH94B Nasal Spray, Aloradine
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 nasal spray developed by Vistagen Therapeutics, Inc. (ticker VTGN) for psychiatric conditions. It is being studied as an acute treatment for anxiety, specifically in adjustment disorder with anxious mood and social anxiety disorder. It is not approved and remains in clinical development.
PH94B is being developed for adjustment disorder with anxious mood and social anxiety disorder. Clinical trials have evaluated it as an acute treatment for anxiety, including anxiety induced by a public speaking challenge in adults with social anxiety disorder. It is investigational and has not been approved for any indication.
PH94B is developed by Vistagen Therapeutics, Inc., which trades under the ticker VTGN. The company is the sponsor of the clinical program studying the nasal spray in psychiatric indications including social anxiety disorder and adjustment disorder with anxious mood.
PH94B is in clinical development, with Phase 2 and Phase 3 trials completed. A Phase 2 trial studied it in adjustment disorder with anxiety, and Phase 3 trials studied it in social anxiety disorder. It is investigational and has not been approved by the FDA.
Completed trials include NCT04404192, a Phase 2 study of PH94B in adjustment disorder with anxiety, and NCT04754802, a Phase 3 study of PH94B nasal spray for anxiety induced by a public speaking challenge in social anxiety disorder. An earlier feasibility study, NCT02622958, also evaluated the nasal spray in social anxiety disorder.
Yes, PH94B Nasal Spray is another name for PH94B. Both refer to the same investigational small molecule developed by Vistagen Therapeutics, Inc. for psychiatric conditions including social anxiety disorder and adjustment disorder with anxious mood.