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news.Health Canada has accepted US-based Sucampo Pharmaceuticals' New Drug Submission (NDS) for Amitiza (lubiprostone), 24mcg capsules, to treat chronic idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
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Amitiza is a prostone and a locally acting chloride channel activator indicated in the US to treat CIC and OIC in adults.
The company said that the effectiveness in patients with OIC taking diphenylheptane opioids has not been established.
In the US, Amitiza is also indicated for irritable bowel syndrome with constipation (IBS-C) (8mcg twice daily) in women 18 years of age and older.
Sucampo chief executive officer Peter Greenleaf said: "Amitiza has been available to patients in the US, Japan, UK and Switzerland, with over nine million prescriptions written in the US alone and continued year over year growth in sales.
"Together with our partner Takeda, we are now focused on making Amitiza available to patients in new markets worldwide, and this new drug submission in Canada is another important step in this process."
All regulatory interactions as well as negotiating approval of Amitiza in Canada is overseen by Sucampo, while Takeda Canada will be responsible for product commercialization in that market.
Amitiza will now be exclusively marketed by Takeda in all global markets, except Japan and China.