Vivus Issues Good News on Diet Drug Front

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Vivus said two late-stage studies of some 3,750 patients showed those who took Qnexa were able to trim their weight by up to 14.7 percent in one study and 13.2 percent in another compared to a placebo group that lost just 3 percent. The studies are the final stage of human trial demanded by the FDA.

A side benefit, Vivus said, was that patients on Qnexa were able to reduce their diabetes risk factors and showed improvement in blood pressure as well. The company said it will ask the FDA for approval by the end of this year.

Obesity – An Epidemic Threatening to Worsen

Some 300 million people worldwide, among them more than 60 million Americans, are considered obese. The World Health Organization said obesity worldwide could increase to more than 700 million people by 2015. Rising rates of diabetes,cardiovascular disease, hypertension and stroke are all linked to obesity.

Pharmaceutical firms are rushing remedies – and hoped-for remedies – to the marketplace, and there are more in the clinical development pipeline.

Analysts say the current market for diet drugs and the anti-obesity market overall is near $1 billion, but believe it could grow to more than $10 billion in the United States alone.

Vivus hopes Qnexa can take a big bite of that market. The drug uses two previously-approved and proven weight loss drugs as its main ingredients, combined in a single daily-dose capsule. Qnexa says its product deals with both appetite and the feeling of being satisfied.

Vivus’s Qnexa Combines Proven Diet Products

The two active ingredients in Qnexa have been around for years, but Vivus says it’s the combination of the pair that had led to successful weight loss in clinical trials. In fact, 67 percent of patients in one study and 70 percent in the other lost at least five percent of their weight in the course of the 56-week trial.

Here’s how each of the drugs work, according to Vivus:

Phentermine is released immediately and helps reduce appetite. It’s been around since the 1950s and is the diet industry’s most-prescribed drug. It was a major component of the recalled diet drug fen-phen, which was linked to heart and lung problems and was taken off the market ion 1997.
Topiramate is time released and used in very low doses to give patients a feeling of satiety, the feeling of being full. Originally an epilepsy drug, it’s also used to help prevent migraine headaches.

Vivus and Qnexa are in a race with two other drug companies to get the next release of a safe therapeutic weight-loss drugs to the U.S. market. Orexigen Therapeutics Inc. and Arena Pharmaceuticals both hope to have a new drug to market soon. Both are using a combination of already approved drugs and hope to introduce their products to market by late this year or early 2010.