More news on the obesity front!Posted: October 12, 2011
Amazing! No less than 10 days after I blogged about Vivus resurrecting their NDA for Qnexa, Orexigen sent out a press release detailing their plan to resubmit their NDA for their obesity drug Contrave.
To give you a little bit of background, the FDA rejected Orexigen’s NDA, despite a majority vote to approve (13 to 7), due to concerns about cardiovascular safety. The FDA ended up “recommending” (I put it in quotes since nothing the FDA recommends is actually optional) that another clinical trial be run to eliminate concerns over over an increase in blood pressure seen during the phase III clinical trials that Orexigen submitted as a part of thier original NDA.
Originally, this caused Orexigen’s leadership to announce they were abandoning Contrave. Details are scarce, but apparently the FDA requested a clinical trial design that was so out of touch with what a company like Orexigen could muster that the company decided it wasn’t even worth discussing.
However, after a period of negotiations with the FDA, Orexigen apparently reached a deal where they could resubmit their NDA if they conduct a cardiovascular safety trial comprised of approximately 10,000 patients. If Orexigen considers that a win, I can’t even imagine what the FDA’s original demand looked like.
So now, Orexigen is estimating that they can complete the trial and resubmit their NDA in 2014. Rather than critique the company’s announcement, I’ll just point you to Adam Feuerstein’s article where he points out the utter ridiculousness of Orexigen’s optimism.
If you don’t feel like reading the article, I’ll give you the cliff notes: Orexigen has $70M in the bank and a conservative estimate for the cost of a 10,000 patient trial is $100M. However, Contrave is being co-developed with Takeda who has much deeper pockets than Orexigen. A more insurmountable obstacle is the time line of NDA resubmittal in 2014. A trial that size will take one to two years, just to enroll all 10,000 patients, never mind administer the drug, collect data, resubmit the NDA and get FDA approval.
If Orexigen/Takeda pulls this off, it will be a victory indeed. I just worry it might be a pyrrhic victory.