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