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news.Cipher Pharmaceuticals, a drug development company, has received tentative approval from the 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.
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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 extended-release (ER), before CIP-Tramadol ER is commercialized.
CIP-Tramadol ER capsules are based on patented oral controlled-release bead technology and feature both immediate-release and extended-release properties.
Larry Andrews, president and CEO of Cipher, said: 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.
We are working diligently on the remaining steps toward commercialization, including securing a US marketing partner and addressing the outstanding intellectual property issues.
Cipher Pharmaceuticals is a drug development company, which commercialize novel formulations of marketed molecules using drug delivery technologies. The Company’s lead compound, CIP-FENOFIBRATE, received final approval from the FDA and Health Canada in the first quarter of 2006.