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."