PITTSBURGH, Pa., Dec. 9 /PRNewswire-FirstCall/ -- GlaxoSmithKline Consumer Healthcare anticipates that on January 23, 2006, the U.S. Food and Drug Administration's joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committees will review the New Drug Application for proposed over-the-counter use of orlistat (tetrahydrolipstatin) 60(mg) capsules in the U.S., to promote weight loss in overweight adults when used along with a reduced calorie, low-fat diet.
"Overweight and obesity are reaching epidemic proportions in the U.S., triggering a cascade of related health issues," said John Dent, Senior Vice President, Research and Development, GlaxoSmithKline Consumer Healthcare. "This advisory committee review is an important step toward a safe and effective OTC weight-loss aid. We have a long and successful history of taking prescription products over-the-counter in a responsible manner, as with NicoDerm CQ(R) and Nicorette(R), and we will work with the FDA to assure appropriate use for OTC orlistat 60 (mg)."
The safety and efficacy of orlistat, which has been available as the prescription drug Xenical(R) (120 mg) in the U.S. since 1999, is supported by more than 100 clinical studies conducted in more than 30 countries, including the four-year landmark XENDOS trial, the longest study ever of a weight loss medicine. More than 21 million people in 145 countries have used orlistat.
Orlistat is a non-systemic weight-loss medication that works in the gut by inhibiting the absorption of dietary fat. Orlistat should be used in conjunction with a reduced calorie diet that contains 30 percent fat or less.
GlaxoSmithKline Consumer Healthcare promotes Xenical(R) in the U.S. following an agreement with Roche and has filed an application with the FDA to sell orlistat 60(mg) over-the-counter. Roche retains marketing rights to orlistat outside of the U.S.
Orlistat (120mg) capsule will remain available by prescription for the prevention of weight regain and the maintenance of weight loss for those who should be treated under the care of a physician, such as those with co- morbidities and children.
About Overweight
Currently, 65 percent (or approximately 130 million) U.S. adults are overweight or obese, according to the National Institutes of Health.(1) Factors that can contribute to overweight include an abundance of high-calorie foods, low levels of physical activity, behavior, environment, and genetics.(2) Overweight can be associated with an increased risk of developing health problems such as hypertension, type 2 diabetes and heart disease.(3)
About GlaxoSmithKline Consumer Healthcare
GSK Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette(R), and NicoDerm(R), as well as many medicine cabinet staples, including Abreva(R), Aquafresh(R), Sensodyne(R) and Tums(R).
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report 2004.
(1) U.S. Department of Health and Human Services "Statistics Related to Overweight and Obesity." http://win.niddk.nih.gov/statistics#preval. Accessed 6.17.05
(2) Centers for Disease Control and Prevention. "Overweight and Obesity: Contributing Factors." http://www.cdc.gov/nccdphp/dnpa/obesity/contributing_factors.htm. Accessed 8.01.05.
(3) Centers for Disease Control and Prevention. "Overweight and Obesity." http://www.cdc.gov/nccdphp/dnpa/obesity/. Accessed 5.04.05.
GlaxoSmithKlineCONTACT: Malesia Dunn of GlaxoSmithKline Consumer Healthcare,+1-412-200-3544, or malesia.a.dunn@gsk.com
