Sucampo CEO Peter Greenleaf said that with more than eight million prescriptions dispensed globally over the past eight years, Amitiza has demonstrated to be an effective treatment option with a well-tolerated safety profile, and we believe in the value Amitiza offers to CIC patients in the UK who are unresponsive to the treatments that are currently available.
"We are pleased by the NICE recommendation as this will make AMITIZA more widely accessible to patients in the U.K. who may benefit from it, thus continuing our mission of meeting unmet patient needs on a global basis," Greenleaf added.
This guidance by NICE’s appraisal committee recommends lubiprostone as an option for the treatment of patients who are considered to be the most difficult to treat, having failed at least two previous laxatives at maximum tolerated doses for a period of six months, and for whom invasive procedures are being considered.
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 (for example educational measures, physical activity) are inappropriate, and was made commercially available in the UK in December 2013.