Cipher’s novel, extended-release formulation of the active ingredient tramadol, which is used for the management of moderate to moderately severe chronic pain, is marketed as ConZip® in the U.S. and Durela® in Canada.
The product is enabled by controlled-release beads in an oral drug delivery technology. The novel formulation means that the product delivers extended-release drug delivery properties, with once-daily dosing, supporting ease-of-use for physicians and a high level of compliance among chronic pain sufferers. Until recently, pain sufferers typically required three to five doses of tramadol per day. Our product’s attributes include rapid absorption and no food effect. Cipher received FDA approval for the product in 2010, completed a marketing partnership with Vertical Pharmaceuticals in Q2 2011 who then launched the product under the trade name ConZip® in Q3 2011.
Health Canada approved the product in Q3 2011. Medical Futures Inc., Cipher's Canadian distributor, launched Durela® in Canada in Q1 2012.
According to IMS, the U.S. market for extended-release formulations of tramadol exceeded $0.10 billion which represents 2.2% of the total tramadol immediate-release and extended-release prescription market. The total tramadol market exceeded 39 million prescriptions in 2012 with an annual growth rate in prescriptions of 8%.