Feasibility Study of PH94B Nasal Spray for Acute Treatment of Social Anxiety Disorder (SAD)

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 Social Anxiety Disorder as defined in the DSM IV of MentalDisorders, which is not secondary to another pre-existing psychiatric condition or toa medical condition.

• Confirmation of diagnosis of Social Anxiety Disorder according to the MINI, 5.0.0

• Clinician-rated Liebowitz Social Anxiety Scale total score ≥60 at both Screening andBaseline visits.

• Clinician-rated HAM-D17 total score <18 at both Screening and Baseline visits.

• CGI-Severity score ≥4 at both Screening and Baseline visits.

• Subject must have:

• experienced and documented a minimum total of six social interaction orperformance events during the two week Screening Period prior to the BaselineVisit, and

• for at least three of these events, must have achieved a peak score of ≥60 on theSubjective Units of Distress Scales (SUDS), as rated in the Patient Diary.

• Women of child-bearing potential must be able to commit to the consistent and correctuse of an effective method of birth control throughout the study and have a negativeurine pregnancy test result prior to study medication administration.

Exclusion Criteria:

• History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder,psychosis, eating disorder, obsessive-compulsive disorder. Any other current Axis Idisorder other than SAD which is the primary focus of treatment. Note that subjectswith concurrent Generalized Anxiety Disorder (GAD) are eligible for the study providedthat GAD is not the primary diagnosis.

• Subjects who meet criteria for substance abuse within the year prior to entry.

• Clinically significant nasal pathology or history of significant nasal trauma, nasalsurgery, or nasal-septal perforation that may have damaged the nasal chemosensoryepithelium.

• An acute or chronic condition, including an infectious illness, uncontrolled seasonalallergies at the time of the study, or significant nasal congestion that potentiallycould affect drug delivery to the nasal chemosensory epithelium.

• Two or more documented failed treatment trials with a registered medication approvedfor SAD during the previous six months, whereby a treatment trial is defined as aperiod of at least six (6) weeks (or longer as documented in package insert for aparticular drug) during which the patient received an adequate dosage (defined as thetreatment dose indicated in the package insert to obtain efficacy for that particulardrug) of the medication.

• Use of any psychotropic medication within 30 days prior to study entry (other thaneszopiclone, ramelteon, zaleplon, or zolpidem for insomnia as described in Section 3.3).

• Concomitant use of non-study anxiolytics such as benzodiazepines or beta blockersduring the study and within 30 days prior to study entry.

• Concomitant use of any over-the-counter, prescription product, or herbal preparationfor treatment of the symptoms of social anxiety during the study and within 30 daysprior to study entry.

• Prior exposure to PH94B.

• Improvement of more than 20% in the LSAS score at Baseline relative to Screening.

• Women who have a positive urine human chorionic gonadotropin pregnancy test prior tostudy medication administration.

• Subjects with clinically significant abnormalities in hematology, blood chemistry,urinalysis, ECG, or physical examination identified at the Screening or Baselinevisit.

• Subjects with a positive urine drug screen at either the Screening or Baseline visit.

• Presence of any clinical condition or disease, or use of a concomitant medication,that in the clinical judgment of the Investigator could place the patient at unduerisk, interfere with study participation, or confound the results of the study.