EU CHMP recommends approval of Airexar Spiromax (salmeterol xinafoate + fluticasone propionate) for treatment of severe asthma and chronic obstructive pulmonary disorder - Teva

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Airexar Spiromax (salmeterol xinafoate + fluticasone propionate), from Teva, intended for the treatment of severe asthma and chronic obstructive pulmonary disorder (COPD) in adult patients.

The benefits with Airexar Spiromax are its ability to improve pulmonary function and symptoms and to reduce exacerbations. Patients should be provided with training by the prescribing healthcare professional to ensure that they understand how to use the inhaler correctly and that they understand the need to breathe in forcefully when inhaling to obtain the required dose. It is important that the patient inhales forcefully to ensure optimal dosing. The most common side effects (frequency at least 1 in 10 patients) are headache and nasopharyngitis. Paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. If this occurs Airexar Spiromax should be discontinued immediately and the patient should be treated with a rapid-acting bronchodilator straightaway. Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat and, rarely, of the oesophagus, can occur in some patients.

Comment: Airexar Spiromax is a hybrid of Seretide Diskus, which has been authorised in the EU since 7 September 1998. Studies have demonstrated the satisfactory quality of Airexar Spiromax, and its bioequivalence to the reference product Seretide Diskus.