A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (4% and 8% w/w Ointment) in Patients With Primary Osteoarthritis Affecting a Single Knee

The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee

Inclusion Criteria:

• Patient is between 40 and 85 years of age, Patient has primary OA in a single knee (target knee) confirmed by American College of Rheumatology criteria.
• For patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics at the time of the screening visit,
• Patient has visual analog scale (VAS) pain scores with acceptable ranges as determined by the investigator during screening
• Except for OA, patient is judged by the investigator to be medically healthy and able to participate in the study.
• Other criteria apply, please contact the investigator for additional information

Exclusion Criteria:

• Patient has secondary or inflammatory arthritis of the knee such as psoriasis, rheumatoid arthritis (RA), gout, other primary bone disease, or acute trauma.
• Patient has symptomatic chondrocalcinosis
• Patient has a history of fibromyalgia.
• Patient has any painful or disabling conditions that in the opinion of the investigator may confound assessment of pain scoring.
• Patient has uncontrolled cardiac, renal, hepatic or other systemic disorders that in the opinion of the investigator may jeopardize the patient.
• Patient has significant edema or skin disorder (including sores, rashes, or ulcers) at the target knee and surrounding area.
• Patient has a history of total or partial knee replacement in either leg.
• Patient had a major reconstructive knee surgery or arthroscopy of the target knee within 6 months before the screening visit.
• Patient is unable or unwilling to discontinue opioid and/or other prescription analgesics for control of OA pain.
• Patient is intolerant to study drug, its excipients, and/or acetaminophen.
• Patient uses any over the counter oral medications such as glucosamine or chondroitin sulfate products, unless the patient has been receiving the medication for ≥3 months at the time of the screening visit and maintains the medication as stable therapy for the duration of the study.
• Other criteria apply, please contact the investigator for additional information