dakyne

Vivus: Obesity Experimental Drug Has Promising Outlook

Nice post Philly Dan. I'm astounded at what passes as (professional) analysis these days.

You touched upon the high points: the limited data points for the Qnexa clinical trials and the long exclusion criteria, relative to Lorcaserin's. There are reasons for this discrepancy: the adverse side effects of phentermine and topamax (both generic compounds, btw). Even if approved, and prescribed to a limited pool, the profit margin on Qnexa would be questionable.


On Jul 08 02:06 PM PhillyDan wrote:

> Only 756 patients in a 28 week study, not a significant study size.
> Exclusions for this study read like a medical dictionary. Weight
> loss results were achieved with highest dosage of both parts of the
> combo drug. Qnexa needs long term safety data like Lorcaserin has
> achieved with the two year Bloom study with over 3000 patients enrolled.
> They have the Sequel study which is an extension of the Conquer study
> to provide this data. Qnexa will not be ready for NDA until late
> 3rd quarter of 2010 and the earliest it could receive PDUFA is July
> or August 2011.
>
> Safety and tolerability will be more favorably viewed than weight
> loss efficacy by the FDA. Most Doctors don't like prescribing combo
> drugs because of the "unintended consequences from overlapping side
> effects". Phentermine raises concern with a number of MD's because
> it only can be prescribed for a certain amount of time, then needs
> to be stopped and restarted.
>
> In my opinion, Qnexa does have a lot of potential but still needs
> to prove itself in safety and tolerability. What the author conveniently
> forgot to mention is the dropout rate of patients in the Qnexa study
> which is quite high.
>
> The Blossom results for Lorcaserin will be announced in September.
> The Blossom study enrolled over 4000 patients at over 131 clinical
> centers around the United States. In addition, the Bloom-DM study
> will be completed soon and that study is tailored to patients with
> Type-II diabetes. Arena will file NDA in December with expected
> PDUFA in October of 2010. Arena has their own manufacturing facility
> in Switzerland that is ramped up and ready to go. That facility
> already does contract manufacturing for other drug companies.
>
> Recommend that you read about Ed Sussman's successful results on
> Medpage Today. Ed is a medical writer for MedPage who was overweight.
> He lost over 52 pounds (the likely assumption is that he was on Lorcaserin
> not the placebo) in 52 weeks. He was able to reduce both BP and
> Diabetes medications as a result of this weight loss.
>
> The obesity market is very large and will be able to handle more
> than one player to provide treatment for people suffering from the
> effects of being overweight or obese. What the author and other
> proponents of either Lorcaserin or Contrave forget to mention in
> their zealousness to promote the one they favor is the fact that
> people are all different. Some people may do better on Lorcaserin,
> others may do better on Qnexa or Contrave to help them lose weight
> and improve the other secondary endpoints. The main thing is that
> they are SAFE first and tolerable. Efficacy is important but should
> be the third thing that is considered in MD's recommending what to
> prescribe for their overweight and obese patients.
>
> I also strongly recommend you do your own due diligence if you wish
> to invest in any or all of these three companies. Based on your
> own due diligence and research, you will make an informed decision
> on which of the three (and there will be more, in fact Neuro Search
> is another company with a promising obesity drug candidate) is the
> best investment for you.