Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company, has 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 http://www.nice.org.uk/guidance/TA318.
About AMITIZA (lubiprostone)
In the U.K., AMITIZA (24 mcg twice daily) is indicated 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.
Important Safety Information (U.K.)
Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating lubiprostone treatment.
There are no or limited data from the use of lubiprostone in pregnant women. Patients who become pregnant or are planning a pregnancy should be advised to consider the risks and benefits of continued AMITIZA therapy during pregnancy.
Nausea is the most commonly reported adverse drug reaction observed in pivotal clinical studies of AMITIZA, with 23.6% of patients experiencing at least one treatment related nausea event; however, of those patients, 93% reported only a single event during treatment with AMITIZA. Of all reported nausea events, 93.7% were mild to moderate in severity, and 4.0% discontinued treatment as a result of nausea. Administration of AMITIZA with food has been shown to reduce symptoms of nausea.
AMITIZA should not be prescribed to patients that have severe diarrhoea. Patients should be aware of the possible occurrence of diarrhoea during treatment. Patients should be instructed to inform their physician if severe diarrhoea occurs.
Dyspnea or chest discomfort/pain (usually described as a sensation of chest tightness and/or difficulty taking in a breath) has been reported shortly after taking AMITIZA, and some patients have discontinued treatment. These symptoms generally resolve within a few hours of dosing, but recurrence has been frequently reported with subsequent doses. If these symptoms occur, the patient should seek medical advice before resuming treatment.
The safety of AMITIZA has been investigated in 301 patients in 3 pivotal clinical studies. During the pivotal clinical studies conducted on AMITIZA, a number of ADRs have been reported. The most common ADR reported by patients taking AMITIZA was nausea, with diarrhoea and headache also being commonly reported. Treatment-emergent adverse events led to premature study discontinuation for 8% of patients in the pivotal clinical studies.
Please visit http://www.amitiza.co.uk for complete Prescribing Information and for further information.