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The Scottish Medicines Consortium (SMC) has announced that that Duaklir Genuair (aclidinium/ formoterol fumarate) has been accepted for use as a maintenance bronchodilator to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) in Scotland.
In Scotland COPD is a major health issue with approximately 105,000 diagnosed COPD patients,2 by 2027 this is projected to increase to 127,000 patients. As such, Professor Bill McKnee, Professor of Respiratory and Environmental Medicine at the University of Edinburgh says the SMC’s decision is “great news”.
“COPD can have a significant impact on a patient’s quality of life with breathlessness (dyspnoea) in particular causing disability and anxiety in patients,” added Prof McKnee.
“There are patients whose symptoms are not controlled by existing treatments who could benefit from alternative treatment options and this decision expands the range of available treatment options for people with COPD in Scotland. Effective treatment can not only improve a patient’s symptoms, but also may reduce the risk of future costly hospital admissions.”
Duaklir® Genuair® is a combination of two established bronchodilators; a long-acting muscarinic antagonist (LAMA) – aclidinium, and a long-acting beta-agonist (LABA) – formoterol fumarate.
In two 24-week comparator- and placebo-controlled phase III studies, treatment with aclidinium/formoterol fumarate 340/12 microgram resulted in statistically significant improvements in FEV1 % (the volume of air that can be expelled in one second after taking a deep breath) predicted pre-dose (versus a LABA) and post-dose (versus a LAMA).
Efficacy and safety data, from more than 4,000 patients, was collated and results from two pivotal Phase III studies, ACLIFORM and AUGMENT, demonstrated that compared to its individual components, twice daily dosing with Duaklir Genuair significantly improves overall symptom control and improves bronchodilation.
Furthermore, Duaklir Genuair has been shown to:
– Reduce moderate to severe exacerbations versus placebo
– Provide tolerability that is comparable to monotherapies
– Provide rapid and sustained improvements in lung function compared to placebo.
Duaklir Genuair is administrated by the multidose dry powder inhaler (MDPI), Genuair which provides successful delivery for 97% of patients.