Cipher Pharmaceuticals Inc announced that it has received tentative approval from the US Food and Drug Administration (FDA) for CIP-Tramadol ER, the company's extended-release formulation of the analgesic tramadol, which is indicated for the management of moderate to moderately severe chronic pain such as osteoarthritis. While the product meets all the FDA's requirements for manufacturing quality, clinical safety and efficacy, the company must resolve certain patent issues related to the reference product, Ultram ER, before CIP-Tramadol ER is commercialized.
"Tentative approval of our extended-release tramadol is another important achievement for our organization and validates the safety and efficacy of this product, which has an attractive profile for a chronic pain medication," said Larry Andrews, president and CEO of Cipher. "We are working diligently on the remaining steps toward commercialization, including securing a US marketing partner and addressing the outstanding intellectual property issues."
Cipher's revised New Drug Application (NDA) for CIP-Tramadol ER was submitted in Q2 2008 as a 505(b) application. Since there are issued US patents for the approved product held by a third party, Cipher was required to certify to the FDA concerning any patents listed in the FDA's Orange Book publication at the time of submission. Cipher's application contained a paragraph III certification acknowledging that the listed patent had not expired and that final approval would be sought after patent expiration in 2014. A paragraph IV certification, which states that the listed patent is invalid, unenforceable, or will not be infringed by the manufacture or sale of the drug, may trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act. To date, this certification has not been filed.
CIP-Tramadol ER capsules are based on patented oral controlled-release bead technology and feature both immediate-release and extended-release properties.
Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies.