Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10, today announced the U. S. launch of Synera® (70 mg lidocaine/ 70 mg tetracaine/ heated topical patch). Synera is approved by the U.S. Food and Drug Administration (FDA) for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions.
Nuvo will be directly marketing Synera to interventional pain doctors with a dedicated 21 person contract sales force. Nuvo believes that there is a significant opportunity for Synera to be used prior to subcutaneous injections for painful needle procedures such as knee drains, epidurals and a variety of nerve blocks. This new sales force will initially target a highly concentrated number of doctors and clinics that perform these painful procedures as a regular part of their practice. Each year, approximately 3,600 U.S. physicians perform 50% of these 23 million interventional needle procedures.
"The launch of Synera is an important milestone for Nuvo as we transition from a purely drug development company into a fully integrated specialty pain company with a dedicated, focused pain specialty sales force," said Dr. Bradley Galer, MD, President of Nuvo's Pain Group. "We believe that Synera has great potential and now represents our second source of revenue, in addition to Pennsaid®. Also, by the end of 2012, we expect E.U. and U.S. approval and the launch of our third commercial product, Pliaglis®, by our worldwide marketing partner, Galderma Pharma S.A."
In the U.S., Nuvo will also be marketing Synera to large national accounts, such as dialysis and infusion centers. Nuvo's U.S. marketing strategy includes out-licensing Synera for the hospital and pediatric markets. Nuvo is in discussion with potential licensees that have the existing infrastructure to sell Synera in those markets.