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news.Cipher Pharmaceuticals has submitted a new drug application to the FDA seeking approval to market its Cip-Tramadol ER, an extended-release capsule formulation of tramadol, for the treatment of moderate to moderately severe pain.
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Cipher’s Cip-Tramadol ER new drug application (NDA) contains data from six completed pharmacokinetic studies and five phase III studies with three of these providing pivotal efficacy data and two providing long-term safety data.
The company expects to have the results of an additional phase III study in the third quarter of 2006. Approximately 2,600 patients have participated in phase III studies, with more than 2,000 patients having received Cip-Tramadol ER.
“Our NDA for Cip-Tramadol ER is supported by a comprehensive data package that shows the product’s key attributes – including rapid absorption, sustainable therapeutic plasma levels at 24 hours and comparable absorption under fed and fasted conditions – which we believe would make it an attractive treatment option in the large but underserved pain management market,” said Larry Andrews, president of Cipher.