A U.S. Double-blind, Placebo-controlled Phase 2 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 Social Anxiety Disorder

Eligibility Criteria

• * Written informed consent provided prior to conducting any study-specific assessment.
• * Male and female adults, 18 through 65 years of age, inclusive.
• * Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
• * Clinician-rated Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening (Visit 1).
• * Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score \<16.
• * Female subjects of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study
• * Subjects must have normal olfactory function
• * Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism spectrum disorder, or obsessive-compulsive disorder.
• * Any other current principal or personality disorder (previously known as Axis I or Axis II disorders), except for specific phobias or generalized anxiety disorder, provided that these are not the primary diagnosis.
• * Subjects who meet criteria for moderate or severe alcohol use disorder within the 1 year prior to study entry, or any use of illicit substances or tetrahydrocannabinol ("THC") within 2 months prior to study entry.
• * In the opinion of the investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study, or the subject is considered to be an imminent danger to themself or others.
• * Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
• * Two or more documented failed adequate treatment trials with a registered medication approved for SAD.
• * Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy.
• * Subjects taking psychotropic medications within 30 days before Visit 2.
• * Use of any over-the-counter product, prescription product, off-label treatment, cannabidiol ("CBD"), or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before Visit 2.
• * Prior participation in a clinical trial involving fasedienol.
• * Participation in any other clinical trial within the last 30 days or during the course of the current trial.
• * Subjects with a positive urine drug screen.
• * Women who have a positive urine pregnancy test.
• * Women who are currently breastfeeding are not eligible unless they are willing to stop breastfeeding for the duration of the study.
• * Subjects who have tested positive and/or have exhibited symptoms consistent with SARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1).
• * Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.