ZARS announces Swedish marketing approval for Rapydan

ZARS, Inc. has announced that the Medical Products Agency in Sweden has approved Rapydan 70 mg/70 mg medicated plaster, a topical local anesthetic patch.

This action represents the first European approval for one of the company's products. Rapydan is the product known as Synera in the United States and was approved by the U.S. Food and Drug Administration (FDA) in 2005. Rapydan is a topical local anesthetic patch approved in Sweden for use on normal intact skin to provide surface anesthesia of the skin for needle puncture and for superficial surgical procedures in adults and for needle puncture in children 3 years and above.

ZARS has entered into a license agreement with EUSA Pharma for Rapydan. EUSA Pharma is a pan-European specialty pharmaceutical company primarily focused in commercializing novel pain, oncology and critical care products. The agreement provides EUSA Pharma with exclusive marketing rights in Europe for the product, which is expected to be commercially available in Sweden mid- year and in additional European countries later in the year, pending additional regulatory approvals. Under the terms of the agreement, ZARS is eligible to receive milestone payments and a royalty on product sales.

"Given their focus in pain, oncology and critical care, we believe EUSA Pharma will be an excellent commercial partner for Rapydan in Europe," stated Robert Lippert, President and CEO of ZARS. "Rapydan may offer several potential benefits to patients because we believe that it is more convenient and has faster onset than other approved products."

Bryan Morton, chief executive of EUSA Pharma said "Rapydan will be an important focus of our sales and marketing teams and we look forward to the upcoming launch."

Rapydan is the first product approved in Europe using ZARS' patented Controlled Heat-Assisted Drug Delivery, or CHADD, technology. Rapydan 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, Rapydan begins to heat, warming the skin upon application. The heating component is intended to enhance the delivery of the local anesthetics into the skin.

Rapydan is applied to intact skin for 30 minutes prior to needle puncture or superficial surgical procedures. In clinical trials, the most common side effect was local skin reactions, such as erythema, edema and blanching. Rapydan 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.

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