FDA approves Symproic once-daily tablets to treat OIC

Shionogi Inc. and Purdue Pharma L.P.'s Symproic 0.2 mg tablets C-II have been approved by the U.S. Food and Drug Administration for use as a once-daily oral peripherally-acting mu-opioid receptor antagonist medication in treating opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
“The FDA approval of Symproic provides a safe and effective therapy for adult patients suffering from chronic non-cancer pain and struggling with opioid-induced constipation,” Shionogi President and CEO John Keller said in a statement. “We believe Symproic will offer a new therapeutic option to help reduce the needless suffering for those who experience OIC.”
Shionogi also submitted a petition to remove Symproic from controlled substance classification; the U.S. Drug Enforcement Agency is reviewing the request. The companies expect to launch and commercialize the product in the U.S. by the middle of the summer.
“By entering this exciting new therapeutic area with Shionogi Inc., we have the opportunity to further help patients with chronic non-cancer pain by offering more comprehensive care to both patients and doctors,” Mark Timney, president and CEO of Purdue Pharma, said.