Sucampo announces publication of NICE recommendation for AMITIZA® (Lubiprostone)

Posted: 23 July 2014 | | No comments yet

Sucampo Pharmaceuticals, Inc. announced that the United Kingdom’s National Institute of Health and Care Excellence has published the technology appraisal guidance recommending the use of AMITIZA® (lubiprostone)…


Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ: SCMP), a global biopharmaceutical company, today announced that the United Kingdom’s National Institute of Health and Care Excellence (NICE) has published the technology appraisal guidance recommending the use of AMITIZA® (lubiprostone) in the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults who have failed laxatives.
The NICE guidance recommends AMITIZA as an option for treating CIC for adults in whom treatment with at least 2 laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and for whom invasive treatment for constipation is being considered.

“We are pleased that NICE has published its recommendation for AMITIZA today, as this will make AMITIZA more widely accessible to patients in the U.K. who may benefit from it,” stated Peter Greenleaf, Chief Executive Officer of Sucampo. “Through more than eight years of experience and eight million prescriptions dispensed globally, AMITIZA has been demonstrated to be an effective treatment option with a well-tolerated safety profile. Today’s NICE recommendation for AMITIZA is an important step in allowing us to fulfill Sucampo’s mission of meeting unmet patient needs in the U.K., and on a global basis.”

NICE regulations require that clinical commissioning groups, National Health Service England and local authorities comply with NICE recommendations within three months of the date of publication. Specifically, the NICE guidance for AMITIZA states that “if a patient has chronic idiopathic constipation and the doctor responsible for their care thinks that lubiprostone is the right treatment, it should be available for use, in line with NICE’s recomendations.”1

“Constipation places a significant burden on the U.K. healthcare system, resulting in over 60,000 hospitalisations annually2,” said Dr. Ramesh Arasaradnam, University Hospitals Coventry and Warwickshire NHS Trust and University of Warwick. “For many of the patients who are refractory to standard laxatives, effectively treating with lubiprostone in primary care could negate the need to progress to a secondary or tertiary care referral.”

According to June Rogers, MBE, Team Director of PromoCon*, “Chronic constipation has a detrimental impact on the quality of life of thousands of patients, particularly in the elderly. PromoCon is delighted that this guidance recognises the burden of chronic constipation, as we believe that providing innovative medicines in primary care will improve the healthcare of CIC patients.”

AMITIZA was approved by the Medicines and Healthcare Products Regulatory Agency in September 2012 for the treatment of CIC and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g. educational measures, physical activity) are inappropriate, and was made commercially available in the U.K. in December 2013.

For the full guidance from NICE on the usage of AMITIZA in the U.K., please visit


  1. National Institute for Health and Care Excellence Technology Appraisal Guidance 318, “Lubiprostone for treating chronic idiopathic constipation.” Issued:  July 2014.
  2. Hospital Episode Statistics 2012/13: Admitted Patient Care. November 2013.