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levonorgestrel and ethinyl estradiol tablets
Generic Name: Lidocaine HCl and Epinephrine Iontophoretic Patch
Date of Approval: May 10, 2004
Company: Vyteris, Inc.
Treatment for: Localized Pain Treatment

The United States Food and Drug Administration (FDA) has approved LidoSite TopicalSystem.
The system has been approved for use on normal intact skin to provide a localanalgesia that numbs the skin prior to the administration of superficial dermatologicalprocedures such as venipuncture (drawing blood with a needle from a vein usuallyin the forearm), intravenous cannulation (administration of fluids and/or medications),and laser ablation (high power laser pulses) of superficial skin lesions levonorgestrel and ethinyl estradiol tablets. Theproduct is approved for use on patients five-years-of-age and older levonorgestrel and ethinyl estradiol tablets.

LidoSite uses an active transdermal delivery technology known as iontophoresis,which administers medications through the skin via a mild electric current levonorgestrel and ethinyl estradiol tablets. The LidoSite system administers lidocaine and epinepherine using a patentedelectrotransport technology that enables the controlled delivery of medicationover a predetermined period of time, from minutes to days levonorgestrel and ethinyl estradiol tablets. Topical anestheticcreams and patches can take up to an hour to numb the skin, while LidoSite worksin 10 minutes levonorgestrel and ethinyl estradiol tablets. This product has successfully completed clinical trials and hasbeen found to significantly decrease pain from needle injections and similarprocedures in both adults and children levonorgestrel and ethinyl estradiol tablets. Lidosite is intended to also addressa strong need in adult applications levonorgestrel and ethinyl estradiol tablets. Its major impact is expected to be in thepediatric population, where pain associated with needlesticks, blood-draw proceduresand immunizations is a major issue for the clinician, child and parent.

Studies Demonstrate Safety and Efficacy
More than 1,000 adults and children (ages 5 to 17 years) participated in clinicalstudies evaluating the safety and efficacy of the Vyteris system in providingtopical anesthesia levonorgestrel and ethinyl estradiol tablets. Two pivotal studies compared the system (administering lidocaine10% and epinephrine 0.1%) with placebo for use prior to needle injections orintravenous (IV) insertions levonorgestrel and ethinyl estradiol tablets. Additional studies evaluated the efficacy of thesystem for use prior to the removal of surface skin lesions (via incision orlaser treatment) levonorgestrel and ethinyl estradiol tablets. Patients treated with Vyteris' LidoSite system experiencedsignificantly less pain associated with needlestick procedures compared withsubjects treated with the placebo system levonorgestrel and ethinyl estradiol tablets. Consequently, fewer patients in theactive group reported experiencing severe pain and most reported feeling littleor no pain in contrast to patients in the placebo group levonorgestrel and ethinyl estradiol tablets. In these studies, thepatients were evaluated using established pain assessment tools including theFacial Affective Scale (FAS) (A = no pain, I = maximal pain) or the Visual AnalogueScale (VAS) (0 = no pain, 10 = maximal pain) methods levonorgestrel and ethinyl estradiol tablets. Evaluations were takenimmediately following patch removal and at 24 hours for side effects levonorgestrel and ethinyl estradiol tablets. Pain scoreevaluations from both scales resulted in statistically significantly less painfor those who used the Vyteris' LidoSite system, as compared to placebo levonorgestrel and ethinyl estradiol tablets. Inthese studies, the most common side effect was mild erythema (skin redness),which disappeared for most patients within 24-hours.
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