New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

2 nd Annual Essentials in Primary Care
Fall Conference
Friday, November 11, 2011
Indacaterol – Arcapta Neohaler
• A long acting beta 2 agonist that increases cyclic AMP levels
which causes relaxation of bronchial smooth muscle. FDA
approved for the long term, once-daily maintenance
bronchodilator treatment of airflow obstruction in patients
with chronic obstructive pulmonary disease (COPD), including
chronic bronchitis and/or emphysema
• Not indicated to treat acute deteriorations of chronic
obstructive pulmonary disease
– In vitro studies have shown that indacaterol has more than 24-fold
greater agonist activity at beta 2-receptors compared to beta 1-
receptors and 20-fold greater agonist activity compared to beta 3-
receptors. This selectivity profile is similar to formoterol.
– The effective half-life, calculated from the accumulation of indacaterol
after repeated dosing with once daily doses between 75 mcg and 600
mcg ranged from 40 to 56 hours which is consistent with the observed
time-to-steady state of approximately 12-15 days.
Indacaterol – Arcapta Neohaler
BOX WARNING: ASTHMA-RELATED DEATH
• Long-acting beta2-adrenergic agonists (LABA) increase the risk
of asthma-related death. Data from a large placebo-controlled
US study that compared the safety of another long-acting
beta2-adrenergic agonist (salmeterol) or placebo added to
usual asthma therapy showed an increase in asthma-related
deaths in patients receiving salmeterol. This finding with
salmeterol is considered a class effect of LABA, including
indacaterol, the active ingredient in ARCAPTA NEOHALER. The
safety and efficacy of ARCAPTA NEOHALER in patients with
asthma have not been established. ARCAPTA NEOHALER is not
indicated for the treatment of asthma.
Wayne Weart
New Drug Update Part I