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FDA approves Symproic for OIC in adults with chronic noncancer pain
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The FDA has approved Symproic once-daily 0.2 mg tablets for the treatment of opioid-induced constipation in adults with chronic noncancer pain, the manufacturer announced.
Symproic (naldemedine; Shionogi, Purdue) is a peripherally-acting mu opioid receptor antagonist (PAMORA), and is currently a Schedule II controlled substance as it is structurally similar to naltrexone, but Shionogi has petitioned the Drug Enforcement Administration (DEA) to deschedule it, according to a press release.
The approval follows the results of the COMPOSE trials, which showed the drug safely and rapidly increased spontaneous bowel movements and complete spontaneous bowel movements in patients with OIC and chronic noncancer pain.
Shionogi and Purdue, who have partnered to commercialize Symproic in the U.S., expect to launch the product mid-summer.
“The FDA approval of Symproic provides a safe and effective therapy for adult patients suffering from chronic noncancer pain and struggling with opioid-induced constipation,” John Keller, president and CEO of Shionogi, said in the press release. “We believe Symproic will offer a new therapeutic option to help reduce the needless suffering for those who experience OIC.”
Disclosures: Keller is employed by Shionogi.