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Analyses demonstrate efficacy of Symlin in Type 1, Type 2 diabetes patients

BY Allison Cerra

PHILADELPHIA — When one of Amylin Pharmaceuticals’ diabetes drugs is used with mealtime insulin, both Type 1 and Type 2 diabetes patients maintain blood sugar in the normal glucose range on a daily basis, according to two analyses presented at the 72nd Scientific Sessions of the American Diabetes Association.

The analyses, which are based off of previously completed clinical studies, aimed to demonstrate how patients taking Symlin (pramlintide acetate) injection treatment (in conjunction with insulin) achieved a greater proportion of blood-glucose measurements in the normal range. In both analyses, researchers looked at each patient’s self-monitored blood-glucose readings before and after breakfast, lunch and dinner, and determined what proportion of those readings fell within the normal range, according to the targets set by American Diabetes Association and the American Association of Clinical Endocrinologists. Normal glucose range was defined as 70-130 mg/dL pre-meal and 70-180 mg/dL post-meal using ADA guidelines, and 70 to less than 110 mg/dL pre-meal and 70 to less than 140 mg/dL post-meal using AACE guidelines.

In the clinical data analysis of 138 patients with Type 2 diabetes, the proportion of measurements in the normal range for Symlin-treated patients increased from 37.2% at baseline to 54.6% at six months, according to ADA guidelines, and from 19.7% to 28.4%, according to AACE guidelines. Similar improvements also were seen in analyses of two studies of patients with Type 1 diabetes. In the first analysis of 218 patients from an open-label clinical practice study, the percent of measurements in the normal range increased from 44.3% at baseline to 52.5% (ADA) at six months and from 27.7% to 32.7% (AACE). In the second analysis of 248 patients from a 29-week, placebo-controlled study, measurements in the normal range based on ADA criteria increased from 37.3% to 43.9% for 115 Symlin-treated patients, compared with an increase from 38.2%to 40.9% in 133 patients receiving placebo.

"These results showed that Symlin, when used with mealtime insulin, helped patients maintain their blood sugar in the normal glucose range on a daily basis," said David Maggs, VP medical research and development at Amylin. "These data provide a ‘real-world’ analysis into the management of daily glucose levels as many patients, whether they have Type 1 or Type 2 diabetes, struggle to maintain target blood glucose levels despite treatment with mealtime insulin."


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FDA accepts Avanir’s IND application for AVP-923

BY Allison Cerra

ALISO VIEJO, Calif. — Avanir Pharmaceuticals confirmed that the Food and Drug Administration has accepted the company’s investigational new drug application for an Alzheimer’s disease drug.

Avanir said the FDA’s acceptance of AVP-923, an investigational treatment of agitation in patients with Alzheimer’s disease, marks the fourth IND for the AVP-923 program. The drug will be evaluated in a phase-2 clinical trial during third quarter 2012.

"With no approved treatments for agitation in patients with Alzheimer’s disease, this remains an area of tremendous unmet medical need," Avanir SVP research and development Joao Siffert said. "We look forward to initiating our clinical research program later this year."


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Seagram’s adds four flavors to sparkling seltzer water line

BY Allison Cerra

ATLANTA — Seagram’s has boosted its sparkling water lineup.

Original Seagram’s sparkling seltzer water is joined by key lime, orange citrus, blackberry raspberry and white peach flavors.

"Whether you’re celebrating a special occasion or just looking for something new and interesting to help unwind at the end of the day, Seagram’s sparkling seltzer water offers the true taste of comfortable sophistication," said Sabrina Tandon, director of new growth platforms at Coca-Cola North America."These beverages are a perfectly simple option that can help you recharge or relax anytime, anywhere."

Seagram’s sparkling seltzer water is available in 12-oz. cans and 1-liter bottles at such retailers as Safeway, Publix, Target, Stop & Shop and Roundy’s.

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