CHMP recommends Rizmoic for opioid-induced constipation.- Shionogi.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Rizmoic (naldemedine), from Shionogi, intended for the treatment of opioid-induced constipation (OIC). Rizmoic will be available as 200-microgramfilm-coated tablets.
The active substance of Rizmoic is naldemedine,a peripherally-acting mu-opioid receptor antagonist which acts in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids without reversing the central nervous system-mediated opioid effects.The benefits with Rizmoic are its ability to inducea clinical relevant increase in the number of spontaneous bowel movements in patientssuffering from opioid-induced constipation. The most common side effects are abdominal pain (7.8%), diarrhoea (5.9%), nausea (3.6%), and vomiting (1.1%). The full indication is: �Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative�.
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