FDA gives tentative approval to pain medication from Cipher Pharmaceuticals

ROCKVILLE, Md. The Food and Drug Administration has given tentative approval to a new drug for managing chronic pain, FDA records show.

The agency granted tentative approval to Mississauga, Ontario-based Cipher Pharmaceuticals' CIP-Tramadol (tramadol hydrochloride) extended-release capsules in the 100 mg, 200 mg and 300 mg strengths. The drug uses patented controlled-release bead technology and features both extended-release and immediate-release properties, Cipher said in a statement. 

"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," Cipher president and CEO Larry Andrews said in a company statement. "We are working diligently on the remaining steps toward commercialization, including securing a U.S. marketing partner and addressing the outstanding intellectual property issues." 

Though several companies make generic versions of tramadol hydrochloride in the 50-mg strength, Johnson & Johnson still holds the patent on the three strengths for which Cipher seeks approval, marketing the drug under the brand name Ultram ER. Because of this, Cipher's approval application to the FDA contained a paragraph III certification under the Hatch-Waxman Act, which means it will seek final approval for the drug after J&J's patent expires in 2014. A paragraph IV certification, which would assert that J&J's patent is invalid, unenforceable or would not be infringed upon, would likely provoke a patent-infringement lawsuit.