A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement

Inclusion Criteria: * Male and/or females indicated for primary, unilateral total knee replacement (TKR) * Between 45-80 years of age inclusive at the time of signing the informed consent * Capable of giving signed informed consent and complying with requirements and restrictions listed in the informed consent form (ICF) and in this protocol * Body Mass Index (BMI) ≤ 40 kg/m2 * Medically stable as determined by the Investigator, based on physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings, as well as medical history from patient and pre-study source documents from other care providers * Absence of moderate to severe fixed flexion deformity * Absence of moderate to severe varus or valgus deformity * Minimum pre-operative flexion arc of 100 degrees * Absence of steroid, hyaluronic acid, platelet rich plasma, or any other type of therapeutic injection(s) in the index knee within 3 months before scheduled surgery * American Society of Anesthesiologists Physical Status Classification System (ASA-PSC) score ≤ 3 * Females of childbearing potential with a negative serum pregnancy test at screening, or males that have a partner who is a woman of child-bearing potential (WOCBP), who agree to employ adequate birth control measures for the full duration of the study. Exclusion Criteria: * Known allergy or hypersensitivity to active ingredient celecoxib, OR known allergy or hypersensitivity to sulfonamide antibiotics or sulfa containing drugs w…