Woooo-hoooo!!!!

No more exercise, no more vegetables, no more fish, no more paleo, no more carb/insulin control, no more protein shakes, no more mindfulness, no more healthy anything…

Qnexa is here and as soon as I get my prescription filled, I am gonna lay a beating on the nearest “all you can eat” restaurant I can find.

Because today is the day that the FDA released their review of  Vivus‘ new anti-obesity drug – Qnexa.

And in that 248 page review, the FDA notes that drug trial participants taking Qnexa lost significantly more weight than those taking a placebo, and that those taking the highest doses of Qnexa lost the most weight.

They also noted that there are concerns about Qnexa side effects – which include depression, anxiety, impact upon heart rate, increased body acids, impaired attention span, impaired memory, impaired attention span, language problems and various risks for pregnant women.

But, who cares about a few side effects?

  • I want my cake
  • I want to eat my cake
  • and I want a six pack

Who cares that Qnexa is the offspring of that old-school diet drug “fen-phen“.

Who cares that by replacing the appetite suppressant phentermine with the anti-seizure drug topiramate, Vivus is praying for a weight loss pill with the effectiveness of fen-phen but without all those pesky fen-phen side effects – pulmonary hypertension, heart valve problems and death.

  • Who cares that fen-phen passed all of the same FDA tests and trials that Qnexa is now passing with flying colors.
  • Who cares that analysts estimate that Qnexa could rake in nearly $689 million in sales by 2014.
  • Who cares that Vivus stock has already risen 20% on the news of this FDA report.

.I want my six pack and I want it now.

.Qnexa…here I come.

.Update:

As of Friday, July 16, Qnexa, the first new prescription weight-loss pill in more than a decade, failed to win backing from U.S. health advisers, who said safety concerns about the drug outweighed its ability to help obese patients shed pounds.

The FDA vote was 10 : 6 against Qnexa.

So, what happens now?

Vivus should have the results of a 2 year Qnexa study by the end of this quarter. If those results are positive, Vivus will take another run at the FDA.

However, things get a bit more complicated for Vivus.

To win FDA approval, Vivus will now have to test Qnexa in as many as 10,000 human patients, at a potential cost of $150 million. And to raise that kind of money, Vivus will probably have to partner up with one of the Big Pharma corps..