Symproic Awarded FDA Approval to Treat Opioid-Induced Constipation
Shionogi and Purdue Pharma received FDA approval for Symproic (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist 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 Drug Enforcement Administration, which is currently under evaluation.
Symproic will be jointly launched and commercialized in the U.S. with Purdue Pharma and is expected to be commercially available by mid-summer.