The UK National Institute of Health and Care Excellence (NICE) has recommended Sucampo Pharmaceuticals’ Amitiza (lubiprostone) as a treatment option for chronic idiopathic constipation (CIC) and associated symptoms in adults who have failed laxatives.

The new NICE guidance is for adults who have tried at least two laxatives at the highest tolerated recommended doses for at least six months, but who have not seen an improvement in their symptoms.

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Sucampo CEO Peter Greenleaf said: "We are pleased that NICE has published its recommendation for Amitiza today, as this will make Amitiza more widely accessible to patients in the UK who may benefit from it.

"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.

"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 fulfil Sucampo’s mission of meeting unmet patient needs in the UK, and on a global basis."

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 institute’s recommendations.

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In September 2012, the Medicines and Healthcare Products Regulatory Agency approved Amitiza for treatment of CIC and associated symptoms in adults, when response to diet and other non-pharmacological measures are inappropriate.

Amitiza was made commercially available in the UK in December 2013.

Safety of Amitiza was evaluated in three pivotal clinical studies which included 301 patients. A number of adverse drug reactions have been reported during these studies.

The most common adverse drug reactions observed includes nausea, diarrhoea and headache. Treatment-emergent adverse events led to premature study discontinuation for 8% of patients in the pivotal clinical studies.