US Food and Drug Administration has approved Cipher Pharmaceuticals Inc's CIP-Tramadol ER, the company's extended-release tramadol product, in adults.
"This represents our second US FDA approval - a major achievement for the company that reflects a significant amount of effort and dedication from our team, led by Dr Jason Gross," said Larry Andrews, president and CEO of Cipher. "We are excited about the opportunity for CIP-Tramadol ER in the large and growing US pain market. There were more than 28 million tramadol prescriptions written in 2009, only 5 per cent of which were for once-daily formulations, indicating there is a substantial opportunity for a new entrant. We believe our product's unique capsule formulation comprising an immediate-release tablet and sustained-release beads, combined with having no food effect, will make it an attractive alternative for clinicians and chronic pain sufferers."
Cipher is currently preparing for the US commercial launch of the product, which includes securing a marketing partner and finalizing commercial manufacturing requirements. The actual timing of the launch will also be influenced by the outcome of the appeal filed by Purdue Pharma Products L.P. against Par Pharmaceutical, Inc, which relates to the Orange Book-listed patents for Ultram ER, the reference product in Cipher's New Drug Application. A decision in that case is not expected until late 2010.
Cipher Pharma is a commercial-stage drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies.