Two years following US approval, Japan’s Shionogi wins EU green light for opioid constipation drug

Nearly two years after winning US approval for its opioid-induced constipation drug, Japan’s Shionogi has secured the European nod for the treatment, naldemedine, in patients that have been previously treated with a laxative.

The drug, to be sold under the brand name Rizmoic in Europe, is an opioid antagonist derived from naltrexone — a prescription medicine mainly used to treat alcohol and opioid dependence. Shionogi’s drug is designed such that it exerts its anti-constipating effects without reversing the analgesic impact of the opioid.

Chronic pain is a common, growing problem that is persistently treated with opioid painkillers, and data suggest constipation is the most common and debilitating gastrointestinal effect of opioid use, with some degree of constipation near universal in patients. The first line of defense is stimulant laxatives, stool softeners, and enemas, but if the problem persists peripherally acting μ-opioid receptor antagonists (PAMORAs) is the class of therapeutics employed.

In the United States, naldemedine (sold as Symproic) was the last PAMORA to win approval. Before it, AstraZeneca’s Movantik (2014) and Salix Pharma’s (a unit of Bausch Health, formerly Valeant) Relistor (2013) were given the nod. The two are also approved for use in Europe.

The efficacy and safety of naldemedine was established in twin 12-week, late-stage placebo-controlled studies in patients with chronic non-cancer pain and OIC, and a separate Phase III was conducted to evaluate long term safety, in addition to comparator studies.

Image credit: Hiromitsu Morimoto

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