New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Indacaterol – Arcapta Neohaler Dose-ranging in COPD • A 2-week, randomized, double-blinded, placebo-controlled design that enrolled 552 patients with a clinical diagnosis of COPD, who were 40 years or older, had a smoking history of at least 10 pack years, had a post-bronchodilator FEV1 less than 80% and at least 30% of the predicated normal value and a post-bronchodilator ratio of FEV1 over forced vital capacity (FEV1/FVC) of less than 70%. The trial compared doses of 18.75, 37.5, 75 and 150 mcg once daily, a salmeterol active control group, and placebo. The trial showed that the effect on FEV1 in patients treated with 18.75 mcg dose was lower compared to patients treated with other indacaterol doses. – Although a dose-response relationship was observed at Day 1, the effect did not clearly differ among the 37.5, 75 and 150 mcg doses by Day 15 Indacaterol – Arcapta Neohaler Like other beta2-agonists, indacaterol can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression, although the clinical significance of these findings is unknown Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Buprenorphine Transdermal System - Butrans by Purdue Pharma • Indicated for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. • A morphine alkaloid. It is a partial agonist at mu-opioid receptors, which mediate analgesia, and an antagonist at kappa-opioid receptors which may reduce abstinenceinduced dysphoria? Buprenorphine Transdermal System - Butrans • The transdermal system is designed to deliver buprenorphine continuously for 7 days. – It is designed with 5 layers: a beige-colored web backing layer, an adhesive rim without buprenorphine, a separating layer over the buprenorphine-containing adhesive matrix, a buprenorphinecontaining adhesive matrix, and a peel-off release liner. The skin is the limiting barrier to diffusion into the systemic circulation. – Steady state is achieved by day 3 during the first application. The 5, 10, and 20 mcg/h patches provide dose-proportional total buprenorphine exposure (area under the curve) following 7-day application. – Following removal of transdermal buprenorphine, the mean buprenorphine concentration decreases approximately 50% in 12 hours (range, 10 to 24 hours), with an apparent terminal halflife of approximately 26 hours. Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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