Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis

Inclusion Criteria:

• At least two episodes of facial pain/pressure/fullness of moderate or severeintensity on a 4-point rating scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe)in the past 30 days prior to the Screening Visit.

• Subject agrees to study-required medication restrictions and the restriction of notstarting new medication to treat CRS symptoms during the course of the study.

• Subject agrees to study-required birth control methods during the course of thestudy, and female subjects must not be breastfeeding.

• No clinically significant abnormality identified on the medical or laboratoryevaluation.

Exclusion Criteria:

• Subject has primary headache disorder.

• Subject has history of nasal or facial surgery within the 6 months prior toscreening.

• Subject has ongoing rhinitis medicamentosa.

• Subject has diagnosed or suspected invasive fungal rhinosinusitis.

• Subject is currently receiving aspirin desensitization or maintenance therapy forSamter's Triad.

• Subject has a history of recurrent acute sinusitis (four or more episodes per yearof acute bacterial rhinosinusitis (ABRS) without signs or symptoms of rhinosinusitisbetween episodes).

• Body Mass Index > 35.0kg/m2

• Subject history of exclusionary medical conditions such as HIV disease,cardiovascular conditions, uncontrolled hypertension or diabetes, psychiatricconditions, drug or alcohol abuse, malignancies, drug allergies, or any significantand/or unstable medical conditions.

• Subjects taking/using excluded therapies.

• Participation in clinical trial with non-biological investigational agents orinvestigational interventional treatments.

• Subjects who have previously participated in any BHV-3000/ BMS-927711/ rimegepantstudy.

• Planned participation in any other investigational clinical trial whileparticipating in this clinical trial.