Active Ingredients: Orlistat
The company didn't set out with any preconceived dosage goal; officials just tried to follow a general principal: "You try and get the lowest effective dose for OTC, says David Schifkovitz, GSK's director of regulatory affairs for weight control projects.
GlaxoSmithKline spent months analyzing studies Roche had done, going back nearly a decade, before prescription Xenical was even approved in 1999.
Full-strength Xenical blocks one-third of the fat a person ingests; OTC orlistat, just one-fourth.
Plus, neither version does anything about sugars or carbohydrates. You lose weight only a slowly, and b by a slight increase per day in the amount of exercise you get and a slight decrease in the amount you eat.
Why should they bother? Obesity medications generally tell users they should exercise and watch what they eat if they really want to lose weight. It improves blood pressure, it improves cholesterol. But an OTC version of the drug would need to rely on its packaging, not a doctor's advice, to communicate all this information.
There's also a Web site with exercise tips, more menu plans, a message board, and a way to create an individualized food schedule. The orlistat educational effort wins praise from Morgan Downey, executive director of the Obesity Society, an advocacy group for physicians.
Other observers are more skeptical.The other, with the proposed name the most promising new drug of works by blocking the body's absorption of fat.
With label changes, the agency approved the OTC application 10 months later. One of the company's most dramatic marketing decisions was to pick a new name. As Burton tells the story, one person picked up the theme, saying, "We're the honest ally in weight loss.
Xenical became alli, pronounced like the noun "ally, and a marketing campaign began. That's alli with a lower-case 'a. But, why not keep the original Xenical name?
Plenty of drugs that go over-the-counter don't switch names, such as Claritin, the allergy medication. Ehrlich, the marketing expert, supports the decision to change the name in this case, as a way to avoid reminding buyers of the original product's unpleasant side effects, limited impact on weight loss, and poor sales.
Burton, however, insists that "Xenical had no bad connotation. Adds Bansal, "Patients use as a positive feedback, as a way to realize that they cheated on their diet.
The company will also not reveal sales, or even how many follow-up packages were bought, only saying that more than 2 million "starter kits" - 60 to 90 capsules, or enough for 20 to 30 days - were sold in the first five months.
Discussion This study shows intraspecies diversity of L. Based on typical pathological symptoms, broadly defined as excessive fat mass in the body specifically the abdomen, the prevalence of obesity has rapidly increased during the last two decades Kobyliak et al.
In spite of the recent intensive research input, a deeper understanding of pathogenesis and the underlying mechanisms of obesity are still lacking, while, in fact, the causality of obesity has been explained from different viewpoints and disciplines of science such as genetics, endocrinology and psychology Schwartz et al.
Thereby, new clinical diagnostic perspectives were opened on the influence of the gut microbiota on the status of metabolic disorders.
This potential has been highlighted in a review by Boulange et al. Indeed, numerous studies have reported on qualitative and quantitative discrepancies in the microbiota of the gastrointestinal tract GIT when comparing healthy subjects with people suffering from metabolic diseases Turnbaugh et al.
There is general agreement that probiotics support the balance of the host gut microbiota, and scientific evidence is steadily accumulating regarding the positive impact of probiotics on human health such as improvement of immune disorders, inflammatory bowel disease, type 2 diabetes and atherosclerosis Amar et al.