Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome

An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome

The purpose of the study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.

ZARS Pharma, Inc. has developed Synera® (lidocaine 70 mg and tetracaine 70 mg topical patch), a drug delivery patch that utilizes controlled heat to enhance the delivery of a local anesthetic formulation consisting of a eutectic mixture of lidocaine and tetracaine. Synera was approved by the Food and Drug Administration (FDA) on June 23, 2005 and is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodesiccation, and shave biopsy of skin lesions.

The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate CTS.

Inclusion Criteria:

• Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
• Have recent (within 3 months) electrodiagnostic evidence of carpal tunnel syndrome (CTS)

Exclusion Criteria:

• Have bilateral carpal tunnel syndrome
• Have another peripheral neuropathy in the affected limb
• Have had an injection into the carpal tunnel within 8 weeks
• Have had surgical release of the target wrist within previous 6 months
• Have electrodiagnostic evidence of severe CTS

Other protocol-defined inclusion/exclusion criteria may apply