December 8th, 2010
Third Time’s the Charm: FDA Panel Finally Backs an Obesity Pill
Larry Husten, PHD
Following rejections earlier this year of two previous anti-obesity drugs, the FDA’s Endocrinologic and Metabolic Drugs advisory committee has recommended approval for Contrave, the combination of sustained-release formulations of naltrexone and buproprion from Orexigen Therapeutics.
The committee voted 13-7 in favor of the drug, saying that the benefits of Contrave outweighed its risks. The committee also voted 11-8 that the company should conduct a large safety trial following approval of the drug. The same panel voted against recommending approval for lorcaserin (Arena) and Qnexa (Vivus) earlier this year.
3 Responses to “Third Time’s the Charm: FDA Panel Finally Backs an Obesity Pill”
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Also all the other anti-obesity pills ended up showing serious MACE and/or Psychiatric events as in the case for the CRESCENDO trial for rimonabant….
The difference in this drug versus the placebo did not quite reach clinical significance. What was the rationalization given by the committee for the positive vote?
Competing interests pertaining specifically to this post, comment, or both:
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In terms of real power, there has been only one obesity drug that has towered above them all – Phen-Fen – it was removed from the market in 1997 due to pulmonary hypertension and valve toxicity. So far there is no simple solution to the mother of almost all disease plagueing the U.S.