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lubiprostone, 24 micrograms soft capsules (Amitiza®)

Advice

following a full submission:

lubiprostone (Amitiza®) is not recommended for use within NHS Scotland.

Indication under review: the treatment of chronic idiopathic constipation and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g. educational measures, physical activity) are inappropriate.

In patients with chronic idiopathic constipation, lubiprostone increased the weekly frequency of spontaneous bowel movements when compared with placebo. Patients treated with lubiprostone reported improved symptom scores for stool consistency, straining and constipation severity compared with patients who received placebo.

The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.

The licence holder has indicated their intention to resubmit.

Drug Details

Drug Name: lubiprostone, 24 micrograms soft capsules (Amitiza®)
SMC Drug ID: 977/14
Manufacturer: Sucampo Pharmaceuticals
Indication: The treatment of chronic idiopathic constipation and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g. educational measures, physical activity) are inappropriate.
BNF Category:
Sub Category: 1.6 Laxatives
Submission Type: Full submission
Status: Not Recommended
Date Advice Published: 11 August 2014

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