Interneuron has reported that its trials with dexfenfluramine in obese patients have provided data at one year showing statistically-significant sustained weight loss compared to placebo, and meet the standards recommended by the US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee.
The company carried out 18 placebo-controlled trials, of which 17 showed statistically-significant weight loss. Bobby Sandage, Interneuron vice president of research and development, said that this "continuous weight control for one year is sufficient proof of [the drug's] long-term efficacy."
Interneuron predicts an FDA advisory committee review for the drug in the first half of this year. The drug is licensed to Lederle in the USA.
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