Once-daily Symproic approved by FDA for OIC patient with non-cancer pain
The US Food and Drug Administration 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.
The drug was developed by Japan’s Shionogi (TYO: 4507) and licensed for marketing in the USA to privately-held Purdue Pharma in late 2016. Shionogi’s shares gained 2.5% to 5,777 yen in afternoon trading in Tokyo.
Symproic is currently a Schedule II controlled substance because it is structurally related to naltrexone. Shionogi Inc submitted a petition for the de-scheduling of Symproic, or removal of the controlled substance classification, to the US Drug Enforcement Administration (DEA), which is currently under evaluation. Symproic will be jointly launched and commercialized in the USA with Purdue Pharma and is expected to be commercially available mid-summer.
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