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news.Cipher Pharmaceuticals has received FDA approval for Cip-Tramadol, an extended-release tramadol product, for the treatment of moderate to moderately severe chronic pain in adults.
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Cipher Pharma is currently preparing for the US commercial launch of Cip-Tramadol, which includes securing a marketing partner and finalising commercial manufacturing requirements.
Cipher Pharma said that the actual timing of the launch is expected to be influenced by the outcome of the appeal filed by Purdue Pharma products against Par Pharmaceutical, which relates to the Orange Book-listed patents for Ultram, the reference product in Cipher’s New Drug Application. A decision in that case is not expected until late 2010.
Larry Andrews, president and CEO of Cipher Pharma, said: “This represents our second FDA approval that reflects the amount of effort and dedication from our team, led by Jason Grossr.
“We are excited about the opportunity for Cip-Tramadol in the US pain market. There were more than 28m tramadol prescriptions written in 2009, only 5% of which were for once-daily formulations, indicating there is a substantial opportunity for a new entrant.
“We believe our product’s 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.”