January 24, 2006
GSK gets panel’s nod to sell OTC version of diet drug
An FDA advisory committee supported GlaxoSmithKline’s request to bring to market what might become the country’s first FDA-approved, over-the-counter weight loss drug.
The panel voted 11-3 to recommend approval of orlistat OTC use in the US, despite some concerns from the agency.
Since 1999 Roche has sold prescription orlistat in the US under the name Xenical in 120-mg capsules. If it receives FDA approval for OTC orlistat, GSK says it would market the drug under the brand name Alli in a 60-mg dose. A final decision could take months.
Alli, designed to inhibit the absorption of dietary fat when taken with meals, would be indicated for use by overweight adults along with a reduced calorie, low-fat diet and exercise program.
The committee voted unanimously that orlistat could be effective as a weight-loss aid taken without a prescription for six months. It also voted that the drug could be used safely over the counter.
However, the drug’s safety profile prompted concern from the FDA. Side effects can include gas, incontinence and oily stools. The agency wondered whether patients could follow instructions on the label of the OTC version. Overall, only 46% of people in a GSK study designed to mirror real-world conditions made the right choice about whether to take the drug.
The agency also questioned the benefits of taking orlistat for six months, because patients could regain the weight.
Additionally, several panel members raised concerns that patients would try the drug even if taking such contra-indicated medications as cyclosporine, a drug taken by organ transpant recipients, and warfarin, a blood thinner.
GSK says the safety and efficacy of Xenical are supported by more than 100 clinical studies conducted in more than 30 countries.
Other companies expected to seek approval for Rx-to-OTC switches for their drugs include Novartis, for heartburn drug Prevacid, and Bristol-Myers Squibb, for cholesterol drug Pravachol.