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We have just received information that GlaxoSmithKline has applied to the European Medicines Agency for a low dose of Orlistat to be sold over the counter throughout the EU.  Orlistat is the active ingredient in Xenical which is already available on prescription throughout the EU at a dose of 120 mg per capsule.  The new low dose of 60 mg will be marketed as Alli.  Alli is already marketed as an over the counter drug in the US and GSK claims that it can help slimmers lose twice as much weight as dieting alone.

The application has been criticised by some healthcare professionals as being irresponsible as it gives the impression that obesity has a quick fix.  There is also concern that the lack of professional advice from a doctor could be detrimental to the patient's health.

It will be some months before we know if the application has been approved and even then it is not certain that GSK will market the product throughout Europe.  We will bring you more news as it becomes available.

We have a number of overweight patients being treated very successfully with Xenical, which is a lipase inhibitor and works locally in the gastrointestinal tract to prevent the digestion and therefore the absorption of fats.  A number of patients who try the medication find that they want to stop taking it after one month as they experience unfortunate side effects such as loose bowel movements and an urgent need to have a bowel movement.  This patient compliance issue means that patients do not achieve the results that they desired as they are not prepared to continue with the treatment if they have to endure the side effects.  (It should be pointed out that for most people, these side effects disappear with an adjustment to diet and most people do not actually get the side effects.)  However, there is a new drug in development with Alizyme – a UK biotech company – which works in a very similar way to Xenical and seems to have similar weight loss results but with relatively few patient compliance issues.  The phase IIb trials demonstrated that it had 90% fewer patient compliance issues when compared with Xenical.

The new drug, known as Cetilistat, is being prepared for phase III trials.  This is a potentially very exciting development as it is not always possible to prescribe the currently available alternatives to Xenical as they are both centrally acting so are therefore not appropriate for a large number of patients.  Having this alternative treatment, which acts peripherally, will be very important for the therapeutic treatment of overweight patients.

Given that Alizyme has not yet announced details of when the next phase of the trials will commence, we are not expecting the drug to come to the market any time soon and we estimate that it could be as late as 2009.