This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of AirDuo™ RespiClick® and its Authorized Generic, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
Although patients receiving systemic corticosteroid therapy are more susceptible to secondary infection than patients not receiving corticosteroids, administration via the inhaled route minimizes this risk. Corticosteroid therapy can mask the symptoms of infection and should not be used in cases of bacterial, fungal, or viral infections that are not adequately controlled by anti-infective agents, except in life-threatening circumstances. Fluticasone; salmeterol should be avoided in patients with tuberculosis infections of the respiratory tract if possible. The incidence or course of acute bacterial or viral infection is probably minimally affected by inhaled corticosteroids in immunocompetent individuals; however, close monitoring of patients with immunosuppression is recommended if treatment with an inhaled corticosteroid is necessary.
Whilst the use of inhaled steroids and long acting beta-adrenoceptor agonists (LABA) are recommended in asthma guidelines for the resulting improved symptom control,  concerns have been raised that salmeterol may increase the small risks of asthma deaths and this additional risk is not reduced with the additional use of inhaled steroids.  Other side effects from this drug combination may include increased blood pressure, change in heart rate, an irregular heartbeat, increased risk of osteoporosis, cataracts, and glaucoma.  With available studies, the safety of inhaled fluticasone propionate cannot be questioned for its effect on growth of asthmatic children. A systematic review published in year 2013,  could not derive any significant adverse effect on HPA function, growth and bone mineral density in asthmatic children when inhaled fluticasone is used for long duration and followed for up to three months.