Shionogi & Co., Purdue Pharma launch commercial plan for naldemedine
The medicine will be used for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain after the current Food Drug Administration review is finished; the companies hope for an action date of March 23 under the Prescription Drug User Fee Act (PDUFA). OIC is one of the most common side effects of opioid treatments in patients with non-cancer related chronic pain.
“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,” Dr. Isao Teshirogi, president and CEO of Shionogi & Co., said. “We firmly believe that Purdue is optimally positioned to bring naldemedine to market.”
Purdue will use their expertise in the care of patients with chronic pain along with Shionogi, the inventor and global developer of naldemedine.
“This alliance brings us into an exciting new therapeutic area and offers us the opportunity to further help patients with chronic pain while advancing our plans to diversify in high need areas adjacent to pain,” Purdue Pharma President and CEO Mark Timney said. “We’ve had a successful, long-term, strategic relationship with Shionogi for two decades and we look forward to continuing our work with them.”