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Orexigen's Contrave: Generic Would Be No Cheaper

What would worry me about Lorcaserin is i didn't realize patients weren't allowed to take SSRI drugs if they were in the trial. Considering the millions and millions of people taking them, how can the fda approve without knowing if this combination is safe? Lorcaserin also acts on the cns, i would be very worried about things like seratonin syndrome with people on ssri's. It's just not realistic to think that people will follow the label especially if doctors don't know what the real risks are.

On the vivus list of exclusions, all of those sounded normal. I wouldn't be surprised if the arna list was similar.

Orexigen's Contrave: Generic Would Be No Cheaper

On the surface Vivus is ahead with better data, that's two strikes against Contrave. Further Orexigen didn't meet the FDA standard of a 5% improvement over placebo (4.3%), while Vivus did (7.5%). I would also argue the Vivus combo is better tolerated and safer. I also have serious doubts about whether Orexigen has the competence to adequately complete a filing for approval given a lot of recent turnover at the top of their company most notably their CSO. On safety, 26% of Contrave patients dropped out, 2X the rate of placebo. I believe for an obesity study usually you'd see the opposite. They also had changed the formulation or titration period as I recall to address major problems with nausea. These drugs are all going to be very carefully reviewed by the FDA. So in sum, I'd tilt the scales toward Qnexa and Vivus over Orexigen and see no reason to own Orexigen stock. I own shares in neither mind you.

Do you disagree with your fellow blog writer Derek Lowe that Arena's candidate won't be approved?

Orexigen's Contrave: Generic Would Be No Cheaper

The question is more whether Orexigen has an approvable concept than generic substitution. I would say it's iffy at this point.