In a joint press release earlier this week, Purdue Pharma L.P. and Shionogi Inc. announced the formation of an alliance to pursue the launch and commercialization of Symproic® (naldemedine) in the United States. The product is indicated for the treatment of opioid induced constipation in adults with chronic noncancer pain, and is under review with the US Food & Drug Administration. The target action date for Symproic under the Prescription Drug User Fee Act is March 23, 2017.
Symproic is a peripherally-acting mu opioid receptor antagonist that is intended for treatment of OIC, among the most common adverse effects associated with long term opioid therapy for chronic pain. Under the terms of the alliance, the participants point to Purdue’s expertise in treating patients with chronic pain and Shionogi’s core competence as the inventor and global developer of naldemedine as key components in bringing the product to the US market.
The press release may be read here.
Posted on December 20, 2016