Diet Pill alli May Also Be Available Over-the-Counter in Europe by Late 2008

Diet pill alli, which is scheduled to go on sale in the United States in mid-summer, may also be available as an over-the-counter diet drug in Europe by the end of next year, according to GlaxoSmithKline.

The company said on April 1st that it plans to seek European approval before the end of this year to sell alli, a low-dose version of prescription diet drug Xenical (orlistat), and hopes to launch the drug in Britain and other European countries by late 2008.

The U.S. Food and Drug Administration gave the go-ahead to alli in February, making it the first weight-loss pill ever approved for over-the-counter sale in the United States.

In Europe as in the United States, hundreds of unregulated products are sold as diet aids in pharmacies and supermarkets, and Glaxo is counting on the blessing by regulators to set alli apart and lead to its use by millions of dieters.

"Consumers spend billions each year on fad diets, unproven miracle pills and potentially unsafe weight loss supplements that may not work," a Glaxo spokesperson said.

"alli is the clinically-proven alternative to these hyped quick-fix products that mislead overweight adults away from weight-loss strategies that are backed by medical science."

"My concern is that it should not be seen as a panacea for people who want to get into a smaller-sized bikini," said Dr. Colin Waine, chair of Britain's National Obesity Forum. "It may also be unpleasant - if you eat a high fat diet you will experience the effects. But if used sensibly with the right sort of dietary back-up then this could help some people."

Wonder weight loss drug to go on sale in UK next year

The battle of the bulge is soon to get a drug-fuelled boost. The first over-the-counter weight loss pill has been licenced in the US and is expected to be approved for use in Britain next year.

Alli, marketed by GlaxoSmithKline, will join dozens of other slimming aids sold in chemists and supermarkets. But unlike them, Alli has been proved to work.

Clinical trials have shown that when combined with a low fat diet and exercise regime over six months, Alli can increase weight loss by 50%, Jean Paul Garnier, head of Glaxo said.

In the US, the Food and Drug Administration gave the go-ahead to Alli last month, triggering a marketing campaign which the company hopes will reap five to 6mn US customers a year.

At a price between $12 and $25 a week (£5-£12), the drug could have annual sales of $1.5bn.
Glaxo said it planned to apply for a European licence by the end of the year with the launch of the drug expected to follow within 12 months. Alli is an over-the-counter version of Xenical, the prescription weight loss remedy launched by the Swiss pharmaceutical company, Roche, in 1999.

Alli contains half the dose of Xenical and will be packaged with guides giving advice on meal planning, what to order when eating out, a fat and calories counter and a journal to record daily food intake.
Two thirds of adults are overweight or obese and the numbers are continuing to rise. Experts believe diet and discipline are not alone sufficient to prevent waistlines expanding and that extra help is required.

The drug works by blocking the absorption of fat from food that is eaten. About one quarter of the fat is blocked with prescription-strength Xenical, but the effect will be reduced in lower strength Alli.
However, the unabsorbed fat has to go somewhere and dieters using it are prone to diarrhoea, its least attractive side effect.

Steve Burton, the Glaxo executive in charge of promoting Alli in the US, has used the drug himself and describes in painful detail the embarrassment it caused when he ate a fish and chip meal with tartare sauce.
The result was a “classic oops” and a dash home for a change of clothes, he told reporters last year.
On the other hand, the drug’s effect provides a powerful incentive to stick to a low fat diet - because the consequences of doing otherwise will be too unpleasant.

Burton, 48, is a walking advertisement for the drug’s success - he lost 65lbs over three years, cutting his weight from 275lbs to 210lbs.
But he warned he had done better than the typical user will do because he had been particularly faithful to his diet and exercise regime. Evidence from trials of Xenical also show that weight loss is temporary - and tends to be re-gained once the drug is stopped.

A spokeswoman for Glaxo in the UK said: “Alli is a fantastic drug if taken alongside a low fat diet and you have a lot of willpower. But it is not a wonder pill and it won’t achieve weight loss on its own. It will be marketed in a very similar way to our smoking control programme where NiQuitin (nicotine gum and patches) comes with advice on giving up smoking, a website and regular messages of support.” – The Independent