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Synera, A New Topical Anesthetic Patch Developed By ZARS Pharma, Is Launched

6/20/2006 10:47:21 AM

SALT LAKE CITY, June 19 /PRNewswire-FirstCall/ -- ZARS Pharma announced today that Endo Pharmaceuticals Inc., launched Synera(TM) in the United States (lidocaine 70mg and tetracaine 70mg). Synera is the first topical patch approved for the prevention of pain associated with superficial venous access and superficial dermatological procedures in patients 4 months of age and older. Endo is marketing the Synera patch through its existing 70-person hospital sales force. ZARS Pharma licensed the North American sales and marketing rights to Endo earlier this year.

"We are pleased that Synera, an exciting and innovative therapy, has been introduced to the market by Endo, a market leader in pain management," said Robert Lippert, President and Chief Executive Officer. "Synera is easily applied, has a familiar adhesive bandage-like appearance, and provides local dermal anesthesia in only 20 to 30 minutes. Endo is uniquely positioned to market Synera to healthcare professionals for their adult and pediatric patients."

Synera addresses an important need in the area of topical pain management, particularly in children. According to published data, children under the age of 15 are hospitalized for an estimated 11.5 million days annually. Hospitalized children are routinely subjected to multiple superficial venous access procedures such as IV infusions and blood draws.

Synera is indicated for local dermal analgesia on intact skin, and consists of a thin, uniform, local anesthetic formulation with an integrated, oxygen-activated heating component that is intended to enhance the delivery of the local anesthetic. The drug formulation is an eutectic mixture of lidocaine 70 mg and tetracaine 70 mg. Synera is indicated to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions. Synera is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, local anesthetics of the amide or ester type, hypersensitivity to paraaminobenzoic acid (PABA), or sensitivity to any other component of the product. Synera should not be used for a longer duration than recommended. In clinical studies, the most common local reactions were erythema (71%), blanching (12%) and edema (12%). These reactions were generally mild, resolving spontaneously after treatment.

About ZARS Pharma: ZARS Pharma 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 are pain management and dermatology. In addition to Synera, ZARS possesses a rich product pipeline of late-stage products that includes S-Caine(TM), ThermoProfen(TM) and Titragesia(TM). Furthermore the Company will be filing additional INDs within the year.

More information about the Company and its technology can be found on its web site at

ZARS Pharma

CONTACT: Gregory S. Ayers, Chief Financial Officer of ZARS Pharma, +1-801350-0202

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