LidoSite

LidoSite

LidoSite

FDA approves LidoSite

The LidoSite system has been approved for use on normal, intact skin to provide local analgesia to the skin prior to performing superficial dermatologic procedures such as venipuncture (taking 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 in patients ages five and older.

What is LidoSite?

LidoSite uses an active transdermal delivery technology called iontophoresis, which delivers medication through the skin via a mild electrical current. The LidoSite system delivers lidocaine and epinepherin using a patented electrotransport technology that allows controlled delivery of medication over a predetermined period of time ranging 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 reduce pain from needle injections and similar procedures in both adults and children. Lidosite is also expected to fill a strong need in adult applications. The greatest impact is expected to be in the pediatric population, where pain associated with needle sticks, blood draws and vaccinations is a major concern for physicians, children and parents.

Studies prove the safety and effectiveness of LidoSite

More than 1,000 adults and children (ages 5 to 17) participated in clinical trials evaluating the safety and effectiveness of the LidoSite System in providing topical anesthesia. Two pivotal LidoSite studies compared the system (delivering lidocaine 10% and epinephrine 0.1%) with a placebo for use before needle injections or intravenous (IV) insertions. Additional studies examined the effectiveness of the system when used before removal of superficial skin lesions (via incision or laser treatment). Patients treated with the Vyteris LidoSite system had significantly less pain associated with needlestick procedures compared to patients treated with the placebo system. As a result, fewer patients in the active group reported feeling severe pain and most reported feeling little or no pain, unlike patients in the placebo group. In these studies, patients were assessed using established pain assessment tools, including the Facial Affective Scale (FAS) (A = no pain, I = maximum pain) or the Visual Analogue Scale (VAS) (0 = no pain, 10 = maximum pain). ) methods. Assessment of side effects was performed immediately after LidoSite patch removal and 24 hours later. Evaluation of pain scores from both scales resulted in statistically significantly lower pain in those who used the LidoSite system compared to placebo. In these studies, the most common side effect was mild erythema (redness of the skin), which disappeared within 24 hours in most patients.

More information