SALT LAKE CITY, Jan. 9 /PRNewswire/ -- ZARS Pharma has entered into a license agreement with Endo Pharmaceuticals for Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch. The agreement provides Endo with exclusive marketing rights in North America for the product that was approved by the U.S. Food and Drug Administration (FDA) on June 23, 2005. Synera is a topical local anesthetic patch for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures in adults and children. Synera is expected to be commercially available mid-year. Under the terms of the agreement, ZARS will receive both milestone payments and a royalty on product sales.
“Given their expanding commercial franchise in pain and anesthesia products, Endo Pharmaceuticals is uniquely positioned to market this product,” stated Robert Lippert, President of ZARS Pharma. “There is a significant clinical need for a new treatment option in reducing the pain associated with common, needle related procedures. Given the product’s relatively fast onset time and simplicity of use, we believe the product should be particularly attractive for use in children.”
Synera is the first product approved by FDA using ZARS’ patented Controlled Heat-Assisted Drug Delivery, or CHADD(TM), technology. Synera is comprised of a thin layer of a patented local anesthetic formulation integrated with an oxygen activated CHADD heating component. When removed from the storage pouch, Synera begins to heat, warming the skin upon application. The heating component is intended to enhance the delivery of the local anesthetics into the skin.
Synera is applied for 20 to 30 minutes prior to venipuncture, vascular access or superficial dermatologic procedures. In clinical trials, the most common side effect was local skin reactions, such as erythema, edema and blanching. Synera should not be used for a longer duration than recommended, and is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine or local anesthetics of the amide or ester type.
ZARS is a specialty pharmaceutical company focused on the development and commercialization of patented technologies that deliver drugs into and across the skin. The Company’s primary therapeutic targets include pain management and dermatology. For more information regarding ZARS Pharma, please see http://www.zars.com .
ZARS Pharma
CONTACT: Greg Ayers, CFO, ZARS Pharma, +1-801-350-0202
Web site: http://www.zars.com//
