When is qnexa on the market

The Obesity Society, the Obesity Action Coalition and other medical organizations have been working with the agency for several years to discuss expanding treatment options for patients with obesity. Some obesity experts have said they feel the FDA is holding weight-loss drugs to a higher standard compared with medications that treat other conditions.

But obesity has severe health ramifications, noted James Zervios, a spokesman for the Obesity Action Coalition. Qnexa targets people with a body mass index of 30 or above or a BMI of 27 or above for people who also have weight-related health problems, such as diabetes or sleep apnea.

A BMI of 25 to 29 indicates overweight and 30 or greater is considered obese. FDA officials are sympathetic to the need, Zervios said. But the potential for Qnexa to cause birth defects appears to be of great concern to the agency. All Sections. Of course, there's good reason for that; numerous weight loss drugs have been found to have dangerous side effects, causing the FDA to reject them. In fact, Qnexa itself was rejected by the FDA in So what's up now? So far, the story's mainly being reported as a business story.

And that it certainly is; the stock of Vivus, Inc. Given past sales figures for diet drugs, Vivus can expect to make a boatload of cash on Qnexa and shareholders will smile all the way to the bank.

One analyst predicted the drug could be the "next Lipitor," resulting in millions of prescriptions. Though Forbes' own Matthew Harper rightly advises caution. In terms of weight loss, Qnexa will likely produce smiles. Clinical data not yet published showed participants lost an average of 10 percent of their body weight, according to Vivus' claims. But as Robert Carlisle's Mr. Let's start with what's in the drug. Qnexa is actually a "cocktail," meaning it's a combination of two previously FDA-approved drugs, phentermine -- an appetite suppressant -- and topiramate, an anti-convulsant.

If you feel like you've heard the name phentermine before, you have -- it's the "phen" from the notorious diet drug cocktail of the s, Fen-Phen, withdrawn from the market for damaging heart valves. Technically a contraction of the chemical name phenyl-tertiary-butylmine, phentermine has a similar pharmacology to amphetamine and works by suppressing appetite.

Because it works by triggering the release of catecholamines, phentermine is known to have two heart-related side effects: tachycardia increased heart rate and elevated blood pressure. These side effects don't happen with the frequency and severity that they do with amphetamines, but patient complaint boards are full of people posting messages about worrisome spikes in heart rate and blood pressure and resulting heart palpitations. Here's how nurse Patricia Nevins describes it: "Phentermine hydrochloride affects the cardiovascular system in much the same way that fear, excitement and anger do.

Essentially an amphetamine, phentermine stimulates the part of the central nervous system that regulates the heart and blood pressure. Physicians prescribe phentermine hydrochloride as part of a weight-loss program because of its ability to increase metabolism and suppress the appetite. The cardiovascular effects of phentermine can cause serious heart problems.

It's important to understand that phentermine is a very old drug, available for more than 40 years. This will be an incredibly challenging judgement for the regulator to make, and one that is very hard to call. It was the cardiovascular safety of Qnexa that dominated the panel hearing yesterday and the issue that will determine how quickly the product gets to market.

The panel were particularly concerned about the increased heart rate seen in patients taking Qnexa; this was despite the fact that the drug improved other important readings including blood pressure and blood sugar levels. Vivus is proposing an 11, patient trial to measure major adverse cardiac events that would take up to five years. By running such a large trial the company hopes to prove the drug actually reduces the risk of these events, as well as establishing its heart safety.

Another panel due to take place at the end of March will discuss cardiovascular issues for obesity treatments. Even if the FDA agrees to a post-marketing study, it could still ask for it to be substantially underway as a condition of approval. Of course Vivus shares are not just soaring on hopes for approval. Obesity is huge untapped market and the first FDA approved therapy for more than a decade represents a valuable proposition.

It seems unlikely a big partner would be willing to commit a big upfront ahead of the final FDA decision and Vivus will no doubt be tempted to hold its nerve, and seek a bigger prize if all goes well. Whether the path will get any shorter is less certain. Open configuration options. Vantage Covid February 23,