Posted by Michael Wonder on 25 Mar 2017
FDA approves Symproic (naldemedine) once daily tablets C-II for the treatment of opioid-induced constipation in adults with chronic non-cancer pain
23 March 2017 - Shionogi and Purdue Pharma announced today that the U.S. FDA approved Symproic (naldemedine) 0.2 mg tablets C-II as a once daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain.
Symproic is currently a Schedule II controlled substance because it is structurally related to naltrexone. Shionogi submitted a petition for the descheduling of Symproic, or removal of the controlled substance classification, to the U.S. Drug Enforcement Administration, which is currently under evaluation.
Symproic will be jointly launched and commercialised in the U.S. with Purdue Pharma and is expected to be commercially available mid-summer.
