Generic Name: Lidocaine HCl and Epinephrine Iontophoretic Patch
Date of Approval: May 10, 2004
Company: Vyteris, Inc.
Treatment for: Localized Pain Treatment
FDA Approves LidoSite
The United States Food and Drug Administration (FDA) has approved LidoSite Topical System.
The LidoSite system has been approved for use on normal intact skin to provide a local analgesia that numbs the skin prior to the administration of superficial dermatological procedures such as venipuncture (drawing blood with a needle from a vein usually in the forearm), intravenous cannulation (administration of fluids and/or medications), and laser ablation (high power laser pulses) of superficial skin lesions. LidoSite is approved for use on patients five-years-of-age and older.
What is LidoSite?
LidoSite uses an active transdermal delivery technology known as iontophoresis, which administers medications through the skin via a mild electric current. The LidoSite system administers lidocaine and epinepherine using a patented electrotransport technology that enables the controlled delivery of medication over a predetermined period of time, from minutes to days. Topical anesthetic creams and patches can take up to an hour to numb the skin, while LidoSite works in 10 minutes. LidoSite has successfully completed clinical trials and has been found to significantly decrease pain from needle injections and similar procedures in both adults and children. Lidosite is intended to also address a strong need in adult applications. Its major impact is expected to be in the pediatric population, where pain associated with needlesticks, blood-draw procedures and immunizations is a major issue for the clinician, child and parent.