Advice
Following a full submission:
linaclotide (Constella®) is accepted for restricted use within NHS Scotland.
Indication under review: symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
SMC restriction: linaclotide is restricted for use in patients with moderate to severe IBS-C who have not responded adequately to or cannot tolerate all other suitable treatment options.
In two pivotal phase III studies linaclotide was superior to placebo for the co-primary endpoints of abdominal pain/discomfort responders and IBS degree-of-relief responders at 12 weeks. There are no comparative efficacy data versus first- or second-line treatments.
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Medicine details
- Medicine name:
- linaclotide (Constella)
- SMC ID:
- 869/13
- Indication:
- For the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
- Pharmaceutical company
- Almirall Ltd
- BNF chapter
- Gastro-intestinal system
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 10 June 2013