Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee

Key Inclusion criteria:

- Male or female patients ≥37 years with moderate-to-severe OA related pain in one knee

- Body mass index (BMI) ≤40 kg/m2

- Symptomatic OA of the index knee diagnosed with a functional capacity of II or III
according to ACR criteria classification Note: Patients with symptomatic contralateral
knee OA with persistent pain ≤2 cm on a 0-10 cm PI-NRS for ≥2 months will be allowed
to participate.

- Unchanged dose of analgesic medication for OA for at least 4 weeks prior to screening
and for the duration of the study

- Able and willing to complete all paper and e-diary assessments required by protocol

Key Exclusion criteria:

- Pain in any joint other than the index joint that could interfere with the patient's
assessment of pain in the index joint

- Compromised integrity of the intact, superficial skin layer

- A grade 1 or 4 Kellgren and Lawrence score on radiographic examination

- Recent injury to either knee causing pain and interference with daily activities (eg.
walking)

- Recent surgery/procedure to either knee causing pain that could interfere with study
assessments of pain, function, and QoL

- Known hypersensitivity or allergy to lidocaine, local anesthetics of the amide type,
or any component of the product