Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers

Inclusion:

• Subject is male or female 18-60 years of age, inclusive.
• Subject is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, clinical laboratory profile, and 12-lead electrocardiogram (ECG).
• Subject is willing to refrain from using any local topical preparations on the volar aspect of the forearms for 24 hours prior to each site visit.
• Subject has normal, intact skin bilaterally at the antecubital area.
• If female, must be of non-childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):

• Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry),
• A vasectomized partner,
• Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to test product administration,
• Intrauterine device (IUD), or
• Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
• If female, must have a negative urine pregnancy test at Screening and at check-in of each Treatment Period.
• Subject is willing to be blindfolded during the study and agrees to abide by all study restrictions and comply with all study procedures.
• Able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.

Exclusion:

• Subject has clinically significant ECG abnormalities at screening.
• Subject is currently receiving class I, II, or III anti-arrhythmic agents.
• Subject has used over-the-counter (OTC) or prescription analgesics within 24 hours prior to either study period.
• Subject has a known allergy or history of significant adverse reaction to any component of the treatment or related compounds.
• Subject has a history of or active use or abuse of illicit drug substance or alcohol abuse.
• Subject has a positive urine test result for drugs of abuse or a positive ethanol breath test at the Screening Visit or check-in to Treatment Visit 1.
• Subject has active dermatological disease of any origin that may interfere with the ability to participate.
• Subject has denuded or broken skin on either forearm.
• Subject has a history of unstable peripheral/vascular disease and/or hypertensive vascular disease.