Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow

Randomized, Parallel-Group, Open Label, Dose Finding Study to Evaluate the Efficacy of Synera Patch Compared to Naproxen Sodium for the Treatment of Lateral and Medial Epicondylitis of the Elbow

The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients with lateral and medial epicondylitis and compare it to Naproxen sodius.

The objective of this single center is to evaluate the safety and efficacy of Synera ® in lateral and medial epicondylitis . This is an open-label, comaparative study study where the subjects will be randomized to one of the following groups:

1. Synera patch ®: A single patch applied for 4 hours twice daily approximatey 12 hrs apart to the medial or lateral side of the index elbow
2. Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of the index elbow
3. Naproxen Sodium: 500mg bid

Inclusion Criteria:

• Individuals with clinical evidence of lateral or medial epicondylitis of the elbow.
• Age 18 or higher
• Minimum of 4 on Question 5 of BPI

Exclusion Criteria:

• Peripheral neuropathy of any origin in the index limb
• Cubital tunnel syndrome in patients with medial epicondylitis
• Cortisone injection in the last 4 weeks into the index limb
• Surgical intervention in the past for the epicondiitis
• Participants in any other clinical trial in the last 30 days
• Known allergy to lidocaine, tetracaine, NSAIDs or PABA
• Uncontrolled pain in the upper extremity or neck that may interfere with evaluation of study drug's response as deemed by the investigator
• Patient who is deemed to be medically unstable by the principal investigator including but not limited to Liver disease or Cardiac arrhythmias
• Patients who are pregnant, lactating or breast feeding
• Vaccination within the last weeks or planning on any vaccinations during the study or for 4 weeks after the study completion.