This month, GlaxoSmithKline will launch alli (orlistat 60 mg), the first nonprescription medicine indicated for weight loss since phenylpropanolamine was taken off store shelves in 2000. GlaxoSmithKline is taking somewhat of a gamble with this launch--betting that the marketing advantage as the only OTC of its kind coupled with a comprehensive behavior modification program will be enough to overcome alli's potential adverse events, which GlaxoSmithKline is terming "treatment effects." Consumers who try alli but who do not buy into the reduced-fat dieting plan are more likely to experience those treatment effects, which could include spotting, oily stools and gas.

There is also potential for abuse, noted Elisa Zeid, a spokeswoman for the American Dietetic Association, as people who may not be a right fit for an alli trial are likely to try alli anyway, such as "people who have just five to 10 pounds to lose [for example], or young people who want to be thin, are in great shape and just want to take off a few pounds even if they're not overweight," she said.

Orlistat 120 mg was first approved as a weight-loss medicine in 1999 for Roche and has been marketed as Xenical since. Roche generated $571 million in global sales of Xenical last year, representing a relatively small market in the pharmaceutical business. Projections for alli in its first year range from a conservative $200 million across all channels to numbers that well exceed Roche's $571 million, which would make alli one of the leading products on OTC shelves.

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