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Our first product is a lidocaine delivery system for local dermal anesthesia. This
product is designed to provide rapid local dermal anesthesia to minimize pain for
medical needlestick procedures, such as insertion of IV catheters, hypodermic
injections (including immunizations), and blood draws, as well as dermatological
surgery procedures.
Initial Lidocaine product
Defining the Need
Providing a Solution
Further Information
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The system is comprised of a patch and a dose controller. The patch
component s a flexible adhesive pad that is pre-filled with a local
anesthetic, lidocaine, along with a small quantity of a vasoconstrictor,
epinephrine. The electronic dose controller is small, reusable, battery-powered,
easily wearable, and is designed to deliver 99 applications.
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- There are over 300 million total needle sticks procedures per year in the US (Bruskin Research)
- There are over 33 million pediatric needlestick procedures performed annually in U.S. hospitals and an estimated 80 million immunization procedures performed in physician offices (Bruskin Research).
- In a recent national survey, 63% of parents considered children's visits to the doctor uncomfortable. The American Red Cross cites pain and fear of needle insertion as a major limitation in their volunteer blood donor program (Bruskin Research).
- Currently no product, short of a direct lidocaine injection, is effective
in rapidly numbing the skin prior to these procedures.
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- Lidocaine is a local anesthetic widely used throughout medical procedures.
- Our patch is designed to deliver lidocaine to the skin without the use of a
needle.
- Vyteris has submitted clinical studies to the FDA, which are still under
review, with a system designed to be effective in both achieving dermal
anesthesia within 10 minutes of application and reducing the pain associated
with needlestick procedures and dermal incisions.
- An NDA for this product was filed with the FDA in 2002. We have partnered with
B.Braun Medical Inc., a full line supplier of innovative healthcare
products & programs, to market our dermal anesthesia product. For
more information on this agreement between Vyteris and B. Braun
please see our press release. For more information about B. Braun or
its safety healthcare products visit B. Braun at www.bbraunusa.com or
call them at 800-854-6851.
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Please refer to the following articles for more information on Lidocaine:
- Zempsky MD, William T, "Lidocaine iontophoresis for safe and efficacious dermal
anesthesia in children", 2002 Pediatric Academic Societies' Meeting Abstract Submission Form
- Lidocaine iontophoresis for safe and efficacious dermal anesthesia. William T.
Zempsky, MD1, Steven Hoath, MD2, Daniel Paulson, MD3, and Paul T. McBride,
MD4. (1)Pain Relief Program, Connecticut Children's Medical Center, University
of Connecticut School of Medicine, Hartford, CT (2) Skin Sciences Institute,
University of Cincinnati, Cincinnati, OH (3) Mcguire Research Institute,
Richmond, VA (4) The Everett Clinic, Everett, WA.
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