Erianne Leatherman | Apr 3, 2017

Symproic receives approval with U.S. launch expected this summer

Shionogi Inc. and Purdue Pharma LP will launch and commercialize Symproic, a medication used to treat opioid-induced constipation (OIC) for adults suffering from chronic non-cancer pain, in the United States as early as this summer.

The partnership follows its recent Food and Drug Administration (FDA) approval, according to a Shionogi press release.

The FDA approved Symproic (naldemedine) 0.2 mg tablets C-II, manufactured by Shionogi and Purdue Pharma, as a once-a-day peripherally acting mu-opioid receptor antagonist medication.

"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," John Keller, president/CEO of Shionogi, said in the release. "We believe Symproic will offer a new therapeutic option to help reduce the needless suffering for those who experience OIC. The launch of Symproic with Purdue Pharma this summer will mark yet another milestone in our commitment to protect the health and well-being of patients we serve.”

The FDA used data from the COMPOSE program, which consists of clinical studies of adults who suffer from OIC and chronic pain not caused by cancer, according to the release.

"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/CEO of Purdue Pharma, said in the release.

Organizations in this story