GlaxoSmithKline Talks About Over the Counter
Weight Loss Pill

The Food and Drug Administration (FDA) recently approved the first ever over-the-counter weight loss treatment pill. The drug, called Orlistat, will be sold under the brand name alli, and is designed to help people lose more weight than with dieting alone.

Steve Burton, GlaxoSmithKline

To find out more about Alli and how it can be used in a sensible weight loss plan, we talked to Steve Burton, the business unit vice president for the weight control division at GlaxoSmithKline Consumer Healthcare, makers of Alli.

Transition to Over-the-Counter

LovetoKnow: How did it come about that Alli would be made available over-the-counter?

Steve Burton: GlaxoSmithKline Consumer Healthcare recognized the need for a safe and effective non-prescription product, because no others exist. We have created a program that includes a plan of diet and exercise, plus a safe and effective product that will enable committed consumers to lose 50 percent more weight than with diet alone. Alli is unique because it works to block some of the fat in the food you eat, and does not affect your brain or your heart.

LTK: What's the process for transferring a drug from a prescription to over-the-counter?

SB: GlaxoSmithKline Consumer Healthcare acquired exclusive over-the-counter marketing rights in the U.S. for Orlistat 60 mg from Roche Pharmaceuticals in July 2004. We filed an application to make Orlistat 60 mg available over-the-counter, with the brand name Alli. The safety and efficacy of Orlistat 60 mg was reviewed by an FDA joint advisory committee, which recommended approving the product for over-the-counter use by a vote of eleven to three. The FDA agreed, and on February 7, issued approval for Alli as the only FDA-reviewed and approved weight loss product soon to be available over-the-counter.

About Alli

LTK: How does Alli work?

SB The Alli program works by helping people understand they are the active ingredient – healthy diet and exercise is essential to any weight loss program. For people who take Alli capsules and follow the program provided through online and in-pack materials, Alli provides a bonus of 50 percent more weight loss than diet alone.

Taken at meal time, alli works by blocking about 25 percent of the fat in the food a person eats. Because of the way it works, alli must be used in conjunction with a reduced-calorie, low-fat diet containing about 15 grams of fat per meal. The guides and information supplied in the alli package help the consumer to control the amount of fat in their meals, and to follow an appealing, reduced-calorie, low-fat diet.

LTK: Who are the best candidates for using Alli?

SB: Alli is for the committed consumer who needs to lose weight and will stick with a reduced calorie, low-fat diet.

LTK: When will it be available? How much will it cost?

SB: Alli will be in stores by the summer 2007. The price will be about $1 to $2 per day and the recommended dose is one capsule with each meal containing fat, up to three capsules a day.

Xenical

LTK: The prescription-strength Xenical will still be available for obese patients. What is the difference between the two products and why should a person choose one over the other?

SB: Xenical is a 120 mg Orlistat capsule and Alli is a 60 mg Orlistat capsule. The products have different indications and dosages. Xenical is prescription orlistat, a 120 mg capsule indicated for the treatment of obesity in patients who require the supervision of a physician. Prescription Xenical has been studied for the treatment of overweight and obesity in such patients for up to four years and carries additional indications, such as preventing weight regain and long-term weight maintenance.

In contrast, alli is 60 mg Orlistat, an over-the-counter (OTC) program indicated for weight loss in overweight adults who follow a reduced-calorie, low-fat diet. As an FDA-approved OTC product, alli puts the consumer in control by offering a proven product with comprehensive support.

Success and Side Effects

LTK: What kind of success do people usually have using the drug?

SB: Alli helps people lose 50 percent more weight than dieting alone. For example, if you lose 10 pounds with a diet, you can lose 15 pounds with diet plus Alli.

In clinical trials, treatment with Alli resulted in a five percent weight loss, and widely available research has shown that as little as a five percent reduction in weight improves health outcomes significantly in overweight and obese people.

LTK: Are there any Alli side effects people should be worried about?

SB: Consumers may experience bowel changes (for example, having to go to the bathroom more frequently), called treatment effects, while on Alli. These treatment effects can be managed when people follow a reduced-calorie, low-fat diet. In fact, anecdotally, users have told us that treatment effects served as a signal that helped them adopt healthier eating patterns. When used as directed, Alli can help millions of people lose weight and adopt healthier eating patterns.

LTK: When should people consult with their doctor before taking Alli?

SB: Although not required in most cases, it’s good advice to discuss any weight loss program with your doctor or pharmacist before you start it. The label on Alli directs users to ask a doctor before use if you are:

• taking medicine for diabetes or thyroid disease. Your medication may need to be adjusted.
• taking warfarin (blood thinning medicine). Your medication may need to be adjusted.
• taking other weight loss products
• having gallbladder problems, kidney stones or pancreatitis

It’s also important to note that you should not take Alli if you have had an organ transplant, if you are taking cyclosporine, if you have been diagnosed with problems absorbing food or if you are not overweight.

LTK: What is the myalli plan and how does it help people lose weight?

SB: Alli provides a comprehensive support program to help people adopt a healthier lifestyle. When Alli is available this summer, purchasers will have access to a free, individualized action plan at Myalli. This program, called myalliplan is one year in length. The first six months focus on diet to help people lose weight. The second six months focus on exercise to help them maintain their weight.

The web site will help people customize their diet, track their progress against their goals, and provide other forms of encouragement and advice to do things, like become more physically active, that are important to longer-term weight management. To help people get off to a successful start, the alli starter packs will include welcome and companion guides, a guide to healthy eating, a daily journal, a calorie and fat counter, quick fact cards, and free access to an individually tailored online action plan at Myalli.

LTK: Anything else you'd like our readers to know about Alli?

SB:' Diet and exercise are the foundation for successful weight loss and we recognize that losing weight requires hard work. Our hope is that alli can be a partner for those working to lose weight. By adding alli to their effort, they can achieve 50 percent more weight loss than dieting alone. That’s a powerful motivator and we hope it will help them continue toward their weight loss goal.

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