Alli (orlistat 60mg) can be purchased OTC in pharmacies by anyone over 18 that demonstrate a body mass index of 28 or higher. It is the first OTC obesity drug to approved in Europe.
The drug, which is a half-dose version of Roche’s prescription drug, Xenical, has been on-market OTC in the US since 2007, and quickly notched impressive, if not blockbuster, sales. It is the only OTC weight loss drug approved by the Food and Drug Administration (FDA) there.
Magic Bullet?
But market analyst, Datamonitor, said while the offering had strong initial prospects, its long-term future was less rosy.
“Pharmacy provision will undoubtedly expand access to the drug: the switch to OTC will allow GSK to raise awareness through direct-to-consumer advertising, which in turn is likely to drive demand from a broad cross-section of society,” Datamonitor said.
“This is a commercial necessity, given that obtaining reimbursement from healthcare providers for weight-loss products is notoriously difficult for pharmaceutical companies. However, as GSK readily admits, Alli is not a magic bullet.”
The slimming ingredients market can be divided into five groups based on the mechanisms of action: increasing energy expenditure; modulating carbohydrate metabolism; increasing satiety or suppressing appetite; increasing fat oxidation or reducing fat synthesis; and blocking dietary fat absorption.
Treatment tactics
Datamonitor said the kind of individuals that sought such treatments may be overweight individuals trying them for the first time and without adequate instruction and supervision, and lifestyle changes, may find negative consequences. “A range of unpleasant (as opposed to dangerous) side effects, exacerbated by poor compliance to usage guidelines and combined with the accepted limitations to the drug's capabilities, require very explicit expectation management,” Datamonitor said.
“Thus, dropout rates for Alli may be higher than in physician-supervised practice (just as dropout rates are higher in real-life settings than seen in clinical trials that typically involve more highly motivated, educated, and managed patients and physicians).”
Such factors have played a similarly constrictive role in the US, the market researcher noted, when Alli went OTC there in 2007. Still, its sales are worth hundreds of millions of dollars.
GSK weight loss petition
GSK waded into the weight management area by lodging an FDA petition last year that called for all weight loss claims to be classified as drug claims and which questioned the efficacy of a number of ingredients typically used in weight loss products such as bitter orange, chromium, guar gum, hoodia gordonia, garcinia, Conjugated Linoleic Acid (CLA), pyruvate and chitosan.
The FDA is yet to rule on the petition despite the 180-day deadline passing.
Globesity
The World Health Organization estimates that by 2015, there will be more than 1.5 billion overweight consumers, incurring health costs beyond $117 billion per year in the US alone.
Obesity is linked to a number of other diseases including type 2 diabetes, some cancers, hypertension, stroke and osteoarthritis.
A recent study published in the Annals of Internal Medicine reported 90 percent of men and 70 percent of women will eventually become overweight.