Vivus Ahead in Race For New Weight Loss Drug

Vivus has been working on a weight loss drug called Qnexa. Qnexa is a combination drug of a generic form of phentermine, an appetite suppressant and topiramate, a drug that is used to treat epilepsy and migraines. The combination of the two drugs apparently gives a one-two punch that is more effectively than the two drugs separately.

Phentermine was an ingredient in the diet pill fen-phen that was recalled in 1997.

The FDA approval process requires a drug to pass two benchmarks to show the drug’s effectivness. The first benchmark is those on the drug must lose more than 5% of their total body weight. The second one is that there must be a 5% point difference in weight loss for those on the drug and those on the placebo.

Vivus has conducted two studies to use as part of their information they will be submitting to the FDA this year as part of the approval process. In one of the studies, 67% of those taking the drug showed a loss at least 5% of their weight.

That compared to 17% for those taking the placebo. In the second study the percentages were 70% of those on the drug compared to 21% of those on the placebo. The actual weight loss for the two studies was 18 to 30 pounds at the completion of the studies.

Another company in the race to request approval for their new weight loss drug is Orexigen Therapeutics. Orexigen released a report in July on three studies they have conducted for their new weight loss drug, Contrave. Like Vivus’ Qnexa, Contrave is a combination drug. Comprised of bupropion, a drug to help with stopping smoking and depression and naltrexone, used to help reduce cravings for alcoholics and opiate addicts.

The studies by Orexigen showed that there were twice as many people lose at least 5% of the body weight that were on Contrave than on the placebo. Orexigen is behind Vivus and the other drug company, Arena in beign ready to ask for approval. It is expected that they will not ask for FDA approval until the first half of 2010.

The third company in the race for a new weight loss drug is Arena. Arena is expected to ask for FDA approval later this year for their weight loss drug, lorcaserin. Similar to fenfluramine which was another one of the drugs in the fen-phen weight loss drug, locraserin is showing no signs of heart or lung problems in the studies by Arena.

In the studies locraserin passed the first FDA benchmark of losing 5% of total body weight. It failed however in not having 5% point difference in weight loss between the drug and the placebo. There was only a 3.6% difference.

The Center for Disease Control estimates that 32 % of Americans are obese. Vivus, Arena and Orexigen are all going after what could be a $10 billion annual market in the weight loss industry. That is why they are racing hard to receive approval of their new weight loss drug.