Why Vivus's Qnexa Might Not Avoid the Obesity Drug Graveyard

Recommended Sources

About Pharma Industry

BNET Pharma provides daily industry trends and news coverage with insights for managers and executives about major manufacturers of pharmaceuticals and medicine. In addition to detailed drug company profiles, we bring you industry analysis on new partnerships, drug patents and products, cost management, investments, pharmaceutical related lawsuits, and a host of other important business issues.

Many have tried. None have succeeded. And now Vivus – a young Arthur of Pharmalot, if you will — believes it can pull the sword from the stone. On paper, it has a good case. My colleague Trista Morrison makes that case cogently here.

Put simply, Qnexa has twice blown through the FDA’s required “5 percent better than placebo” weight-loss standard. And if this press release is to be believed, there are no significant safety problems.

What could possibly go wrong? Three things:

History: The history of diet drugs is simple to understand. They either don’t work, are dangerous, or are effective but so unpleasant that — like GlaxoSmithKline’s Alli – few can stand to use them. So on the track record alone, if you think Qnexa is $10 billion-a-year drug, you’re betting against history.
Qnexa is a speed-based antidepressant: This drug is literally a mixture of the amphetamine phentermine and the epilepsy/antidepressant drug topiramate (Topamax). And while Vivus’s testing has not turned up any major side effect signals, the Qnexa proposition essentially asks doctors to prescribe the drug to patients who are neither depressed nor epileptic nor fatigued. Is it likely that widespread use of such a mixture will lead to zero worrying side-effect signals?
Qnexa is too effective: Remember, to succeed it is not good enough to simply be effective. Wyeth’s infamous Fen-Phen was effective. Cocaine and cigarettes are effective. It’s just that extended use of these products results in death. In Vivus’s most recent test, patients lost up to 13.2 percent of their body weight. That’s fine if you weigh more than 250 pounds, as the patients in the test did. But it’s ruinously unhealthy if you weigh around 120 pounds or less. Thus, the FDA may ban it for patients who aren’t fantastically heavy — and that could restrict its revenues.

We’ll see. $10 billion in sales are on the line, if the bulls are to be believed.

Image by Flickr user Qole Pejorian, CC.

Tags: Patient, Vivus, Qnexa, Federal Government, Government, Jim Edwards

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

BNET User Analysis

Voice your 2cents

Web Buzz:

A Realistic Transition Toward the "Paperless" Medical Practice

ZDNet - 38 days 2 hours 35 minutes ago

I was playing Twister with a nimble young friend from Ricoh the other day when I pulled a muscle trying to get to red. I told her how much I hate going to the doctor because of all the paperwork you have to fill out. “Well then,” she said, “Give this to your doc, Doc.” And she handed me a new white paper from Ricoh on how medical...
Grab a Super Big Gulp of 7-Eleven's New $3.99 Vino for the Masses

Fast Company - 16 days 20 hours 23 minutes ago

Now you can pull off the road, pop into 7-Eleven and grab a chardonnay with stone fruit tones or a plum-like cabernet sauvignon, both of which pair perfectly with Go-Go Taquitos or a 1/4-pound Big Bite. 7-Eleven's new brand of house wines, Yosemite Roads, is cheaper than a 6-pack, too--$3.99 a bottle. The convenience store chain best known...
Now, even Apple's mouse is multi-touch

BetaNews - 33 days 1 hour 7 minutes ago

By Tim Conneally , Betanews Continuing Apple's incremental shift away from button-based interfaces and toward multi-touch everything, Cupertino today unveiled the Magic Mouse , an acrylic Bluetooth mouse where "the entire surface is a button." Apple has done to the mouse almost exactly what it did to the trackpad in 2008, it has turned...
Lucas Watson

Ad Age - 62 days 14 hours 23 minutes ago

BATAVIA, Ohio (AdAge.com) -- Many have tried getting Procter & Gamble Co. marketers to use more digital media over the years. Lucas Watson has set himself apart by succeeding like none before
Twitter @replies Saga: Oops, But the Feature Isn't Coming Back

Wired - 190 days 23 hours 53 minutes ago

Twitter's Biz Stone falls on his sword for creating a rare bad PR week for the mindcasting medium, saying he blew the message. But the arcane feature at the heart of "the replies kerfuffle," which Twitter pulled unilaterally and without warning, well, that's not coming back.

BNET TalkbackShare your ideas and expertise on this topic

Subscribe to this discussion via Email or RSS

1

Trista Morrison

09/14/09 | Report as spam

RE: Why Vivus's Qnexa Might Not Avoid the Obesity Drug Graveyard

Well played.

As clean as the data look thus far, I think point #2 above is the biggest potential stumbling block.
2

Rafi Allos

09/15/09 | Report as spam

RE: Why Vivus's Qnexa Might Not Avoid the Obesity Drug Graveyard

While I agree that some healthy skepticism is always required and has been missing from some of the very bullish Articles written in the wake of Vivus's most recent announcement of Qnexa data, I feel I must disagree with some of the points made in your article.

Firstly, topiramate is an anti-eleptic that has also been approved for a number of small/niche indicaitons in various countries. It is not an anti-depressant (buproprion, which is a component in both of Orexigen's drugs, Contrave and Empatic, is an anti-depressant). Topiramate does in fact have depressive effects in a certain sense but this is not from a mental health perspective because instead from a sympathetic nervous system perspective. It therefore anatagonises some of phentermine's stimulatory effects on the SNS (i.e. dry mouth sensation, slight increase in blood pressure).

Furthermore, it is very important to note that even full dose Qnexa is a combination of phentermine and topiramate at doses much lower than the highest doeses approved of either of the constitutent drugs. Vivus, according to the results conference, are hoping to get all 3 dose levels of Qnexa approved to give doctors maximum presciption flexibility and furthermore, management indicated that the mid-dose would be used in most patients with high-dose only be used in non-responsive patients.

Secondly, it is fundamentally incorrect to extrapolate the results in obese and morbidly obese patients to people who weigh 120 pounds. The more excess fat that a person carries the greater and the more rapid weight loss will be on an energy restricted diet. Qnexa's primary mechanism is a reduction in calorie intake as a result of decreased appetite and increased satiety and is effective because it helps obese and overweight patients to consume an energy restricted diet.

If approved, regulatory agencies will likely approve it only for patients who are overweight and have another co-morbidity such as diabetes or hypertension and for patients who are obese. As a prescription-only drug it will therefore only be legitimately available to patients who satisfy that criteria and who obtain a prescription from a doctor. It does not therefore need to be "banned" from patients who weigh less but will simply never be submitted for approval for those who are mildly overweight but healthy. The fact that the drug might be sold on the internet without a prescription to people who do not fall within the patient criteria is a different matter...

As I said at the beginning of my post I do feel some skepticism is warranted, especially in the obesity drug development field. However, in my opinion that skepticism should centre around the potential commercialisation problems of a drug, albeit a patented combination, that combines two generic agents and any potential central side effects. The latter should be assessed by combing through the release of data by Vivus as more detail is put forward rather than speculation based on the constitutent agents that is shaky.

Disclosure: I hold shares in Vivus and Orexigen
3

BNET's Jim Edwards

09/15/09 | Report as spam

RE: Why Vivus's Qnexa Might Not Avoid the Obesity Drug Graveyard

Obviously docs should not be prescribing Qnexa for 120lb women, but we all know that drugs have a tendency to leak off label. And how many of us have had a 117lb friend insist that she just needs to lose another 12lbs?