Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)

Inclusion 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 ofMental Disorders, 5th Edition, and confirmed by the Mini-InternationalNeuropsychiatric 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 consistentand correct use of an effective method of birth control throughout the study

• Subjects must have normal olfactory function

Exclusion Criteria:

• Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder,psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism spectrumdisorder, or obsessive-compulsive disorder.

• Any other current principal or personality disorder (previously known as Axis I orAxis 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 1year 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 suicidalbehavior during the course of their participation in the study, or the subject isconsidered to be an imminent danger to themself or others.

• Clinically significant nasal pathology or history of significant nasal trauma, nasalsurgery, total anosmia, or nasal septum perforation that may have damaged the nasalchemosensory epithelium.

• Two or more documented failed adequate treatment trials with a registered medicationapproved for SAD.

• Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, oracceptance 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 anxietyor 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 thecourse 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 tostop breastfeeding for the duration of the study.

• Subjects who have tested positive and/or have exhibited symptoms consistent withSARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1).

• Any clinically significant medical history or findings as determined by theInvestigator that could interfere with the objectives of the study or put theparticipant at risk.