A Phase 3 Study to Evaluate the Long-Term Safety of ThermoProfen™ in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee.

An Open-Label, Long-Term Safety Study to Evaluate the Safety of ThermoProfen™ for the Treatment of Mild to Moderate Pain Associated With Osteoarthritis of the Knee

ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate the safety of long-term administration of ThermoProfen™ for the pain associated with osteoarthritis of the knee in adults. The study will be conducted in patients with pain associated with osteoarthritis and who have completed a previous efficacy study of ThermoProfen.

The objective of the study is to evaluate the safety of long-term administration of ThermoProfen for the pain associated with osteoarthritis of the knee in adults.

Inclusion Criteria:

• Patient completed a previous efficacy study of ThermoProfen.

Exclusion Criteria:

• Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin).
• Patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in ThermoProfen (such as that found in adhesive bandages, e.g. Band-Aid®).
• Patient has asthma that has been induced or made worse by the use of aspirin or any other NSAID.
• Patient has a relevant history of serious gastrointestinal disease.
• Patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
• Patient has neurological or psychiatric disease sufficient to compromise data collection or integrity.
• Patient is taking warfarin, heparin, or low molecular weight heparin.
• Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.