The FDA has approved a new weight loss drug for over-the-counter purchase – Orlistat.
Orlistat has been available in a prescription form (called Xenical) since 1999. Orlistat will be the first FDA approved weight loss drug that is available without a prescription.
The over-the-counter form of Orlistat, which will be called Alli, is expected to debut this summer. The manufacturer instructs the medication should be taken three times a day, before meals, in conjunction with a low-fat diet and a regular exercise program.
The FDA says the safety of Orlistat has been well established. The drug has been used by 25 million people in 146 countries.
The drug’s effectiveness has been evaluated in more than a hundred clinical trials involving 30,000 patients. The results of these studies demonstrate that while diet and exercise facilitate weight loss, taking orlistat in conjunction with these lifestyle changes promotes even greater weight loss.
In a recent study known as the Xendos trial, researchers evaluated the effects of orlistat in more than 3,000 obese individuals engaged in a weight-loss program that included diet and exercise. Half of the subjects received orlistat, while the other half were given placebo pills.
After one year, the orlistat users had lost an average of 25 pounds, compared to an average weight loss of 16.5 pounds among those taking the placebo.