GSK Applies to Sell Obesity Drug Off-Prescription
The pharmaceutical manufacturing firm GlaxoSmithKline today announced that it has made an application for the licence required to sell its drug Orlistat over-the-counter. If successful, GSK's weight-loss product would become the first drug in its class to be available without prescription in Europe. The same drug is already approved for non-prescribed sale in the US, where it goes by the name of 'Alli'. In respect of the progress of its new application, GSK confirmed the European Agency for the Evaluation of Medicinal Products (EMEA) had accepted Orlistat for review.
Orlistat comes in 60mg capsules, and is designed to be taken three times daily. It can assist with generating weight loss in its patients at a level 50 per cent greater than standard dieting. However, it requires the support of a specific diet to counter the otherwise unavoidable side effect of unmanageable diarrhoea. It works by reducing the level of fat absorbed by the body.
In America, Alli comes complete with literature promoting healthy eating, a diary, a calorie/fat measuring device and other support material.
Within its announcement, GSK emphasised how it viewed the chance of a response from the European regulator unlikely within the next 12 months. On that basis, its launch will probably not happen until 2009.
Obesity has, in recent times, become of the most frequently recorded lifestyle diseases in the western world. As well as carrying a greater chance of premature death, it also heightens the risk of heart problems, type 2 diabetes and some forms of cancer.
In the latest figures available to Pharmaceutical International, 23.1 per cent of UK men and 24.8 per cent of UK women were considered obese. This data is from 2005, and represents an increase of nearly 10 per cent and over eight per cent (respectively) compared to figures from twelve years earlier.
Even more dramatically, two years ago, nearly 871,000 prescriptions were issued in respect of obesity. Just six years before, the comparable figure was around 127,000 - a 585 per cent increase.
According to GSK's John Clarke - who presides over the drug firm's consumer healthcare strand - "We've said all along that this (Orlistat) is no magic pill. If people are looking for a quick fix, this is not it but it is a powerful motivator."
Source - Pharmaceutical International's Research and Development Analyst
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