Shionogi and Purdue Pharma announced that the 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 (OIC) in adult patients with chronic non-cancer pain.
Symproic is currently a Schedule II controlled substance because it is structurally related to naltrexone. Shionogi Inc. submitted a petition for the descheduling of Symproic, or removal of the controlled substance classification, to the U.S. Drug Enforcement Administration (DEA), 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 mid-summer.
“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,” said John Keller, president and chief executive officer, Shionogi. “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 approval of Symproic was based on data from the COMPOSE program, a global comprehensive development program comprised of clinical studies conducted in adult patients with OIC and chronic non-cancer pain. It was comprised of three studies: COMPOSE I, COMPOSE II and COMPOSE III. COMPOSE I and II were 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, while COMPOSE III was a 52-week, randomized, double-blind, placebo-controlled, long-term safety study.
“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,” said Mark Timney, president and chief executive officer, Purdue Pharma. “The approval of Symproic marks a significant advancement in our partnership with Shionogi as well as the diversification of our product portfolio.”