Rizmoic (naldemedine) - which is commercialised in the UK by Sandoz Ltd - will be available on the National Health Service to treat patients with opioid-induced constipation who have already tried a laxative.
The drug is an oral peripherally acting mu-opioid receptor antagonist (PAMORA), approved in Europe on the back of evidence showing that is increases the frequency of bowel movements compared with no treatment and other PAMORAs.
In two of studies, involving 1,095 patients taking opioids for chronic pain caused by a condition other than cancer, 50% of patients taking Rizmoic for 12 weeks achieved the desired outcome, compared with 34% of patients taking placebo.
In two other studies, involving 307 patients taking opioids for cancer pain, 74% of patients taking Rizmoic for two weeks achieved the desired outcome compared with 36% of patients taking placebo.
NICE noted that the drug's cost-effectiveness evidence is based on several clinical scenarios, for both pure opioid-induced constipation and mixed aetiology constipation, and concluded that in all these scenarios the most likely cost-effectiveness results fall within what it normally considers an acceptable use of NHS resources.