ZARS Announces FDA Approval of Synera Local Anesthetic Patch
SALT LAKE CITY, July 26, 2005 -- ZARS, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Synera, a topical local anesthetic patch, developed under the name of S-Caine Patch (lidocaine 70 mg and tetracaine 70 mg). This is ZARS’ first product to be approved by the FDA.
The patch will be used to numb the skin before various medical procedures such as superficial venous access as well as certain dermatological procedures. The product is indicated for use in children and adults and will soon be for sale in the U.S.
Synera has a thin layer of a local anesthetic formulation integrated with an oxygen-activated heating element. The heating element enhances the delivery of the local anesthetics into the skin. When removed from its storage pouch, the patch begins to heat, warming the skin after application.
In clinical trials, the most common side effect was local skin reactions, such as erythema, blanching and edema. 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.
Larry Rigby, ZARS’ CEO, stated, "We are thrilled with the FDA approval. Synera will provide a new option in reducing the pain associated with common procedures, and will, we believe, be an excellent option for use in children. The FDA’s approval is also a major milestone for ZARS, showing that our team is capable of developing and getting to market through the NDA process innovative medical products that improve patient care."
ZARS filed an application to market Synera in Europe last April.
Source: ZARS, Inc.
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