The pharmaceutical company Orexigen Therapeutics Inc today issued a statement saying that late-stage trials of their new weight loss pill Contrave have showed that the medication definitely could help obese people lose weight.
There had previously been questions over whether the pills, previously called Excalia,would meet the standards set by the Federal Food and Drug administration for public sale. However the company say the latest set of trial results exceeded the FDA benchmarks. 48% of patients taking the high dose of Contrave lost at least 5% of their body weight, compared to 16.4% taking the placebo.
The FDA say that there needs to be at least a 5% difference between the weightloss noted in the group taking the medication and the group taking the placebo.
Over a year, the trial saw 3,800 patients take either the medication, a combination of the anti-depressant Wellbutrin and the anti-addiction drug naltrexone, or the placebo. The pills were given at three different levels, the high dose, the medium dose and the low dose. While Orexigen say they will not be continuing the low dose trials as the results were negligible, at a medium dose patients had a mean weight loss of 6.1% of their total body fat compared to the 1.6 loss of the placebo group.
Orexigen say that they plan to file for FDA regulatory approval in the first half of 2010.