LidoSite

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.

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Studies Demonstrate LidoSite Safety and Efficacy

More than 1,000 adults and children (ages 5 to 17 years) participated in clinical studies evaluating the safety and efficacy of the LidoSite system in providing topical anesthesia. Two pivotal LidoSite studies compared the system (administering lidocaine 10% and epinephrine 0.1%) with placebo for use prior to needle injections or intravenous (IV) insertions. Additional studies evaluated the efficacy of the system for use prior to the removal of surface skin lesions (via incision or laser treatment). Patients treated with Vyteris' LidoSite system experienced significantly less pain associated with needlestick procedures compared with subjects treated with the placebo system. Consequently, fewer patients in the active group reported experiencing severe pain and most reported feeling little or no pain in contrast to patients in the placebo group. In these studies, the patients were evaluated using established pain assessment tools including the Facial Affective Scale (FAS) (A = no pain, I = maximal pain) or the Visual Analogue Scale (VAS) (0 = no pain, 10 = maximal pain) methods. Evaluations were taken immediately following LidoSite patch removal and at 24 hours for side effects. Pain score evaluations from both scales resulted in statistically significantly less pain for those who used the LidoSite system, as compared to placebo. In these studies, the most common side effect was mild erythema (skin redness), which disappeared for most patients within 24-hours.

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