This research will develop an effective topical medication for the treatment of genital herpes lesions using tetracaine as the active. ViroTex has found clinically that a topical cream containing 2% tetracaine with 1% sodium lauryl sulfate (the OTC product Viractin) reduces the time to healing of herpes labialis lesions by 30%. By use of in-vitro skin permeation methodology, a topical tetracaine formulation having optimized drug delivery properties will be determined. Confirmation of earlier studies which indicated that tetracaine has antiviral activity will guide formulation efforts. If tetracaine can inhibit herpes simplex virus type 2 replication, then maximum delivery across intact skin is preferred to most effectively treat during the prodrome and papule state of lesion development. The combination of virology studies, drug delivery characterization, and product characterization efforts will provide the information necessary for completion of an Investigational New Drug application. Based upon ViroTex's clinical results with Viractin_, once approved the ViroTex topical product for genital herpes would be the only approved topical for the acute therapy of recurrent outbreaks for genital herpes. A year of treatment using the ViroTex topical is projected to cost the patient $40 compared with $1200 per year for suppressive Zorvirax therapy.National Institute of Allergy and Infectious Diseases (NIAID)
