FDA accepts Avanir’s IND application for AVP-923
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."
Seagram’s adds four flavors to sparkling seltzer water line
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.
Study: Insulin degludec reduces risk of nocturnal hypoglycemia among Type 2 diabetes patients
PHILADELPHIA — An investigational insulin being developed by Novo Nordisk significantly reduced the rate of hypoglycemia at night in adults with Type 2 diabetes, according to results of a late-stage clinical trial presented at the 72nd Scientific Sessions of the American Diabetes Association.
Novo Nordisk said during a 52-week randomized, open-label, noninferiority, treat-to-target trial, its ultra long-acting insulin degludec reduced the rate of nocturnal hypoglycemia while obtaining equivalent improvement in glucose control, compared with insulin glargine. Both insulins were given once-daily in 1,030 insulin-naïve Type 2 diabetes adults inadequately controlled with oral antidiabetic medications.
Insulin degludec was submitted for once-daily use to the Food and Drug Administration in September 2011 for regulatory review.
"Nocturnal, or night-time, hypoglycemia is a particular challenge for people living with diabetes, as these episodes are often unpredictable and difficult to detect," said Bernard Zinman, lead author and director of the diabetes center at Mount Sinai Hospital, and professor of medicine at the University of Toronto. "This study demonstrated that treatment with insulin degludec significantly reduced the rate of nocturnal hypoglycemia."