The medication is currently in FDA review. The target action date, under the Prescription Drug User Fee Act, is March 23.
“Shionogi is very pleased to create this alliance with Purdue, which is well established as the U.S. leader in providing treatments for those burdened with chronic pain,” Shionogi President and CEO Dr. Isao Teshirogi said. “We firmly believe that Purdue is optimally positioned to bring naldemedine to market, following approval by FDA for the treatment of OIC in adult patients with chronic non-cancer pain, to benefit the appropriate patients and to the healthcare providers that care for them.”
Purdue will bring to the collaboration its leading expertise in pain management in patients, which will be combined with Shionogi’s inventor and global developer knowledge. Along with launching and commercializing Symproic, Purdue and Shionogi will also include all aspects regarding strategy, sales and other activities.