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Nektar Therapeutics (NKTR) Message Board

  • hoyas012 hoyas012 Sep 27, 2013 1:23 PM Flag

    181 -- non-event

    Only one thing matters as far as 181 is concerned, and that is how badly FDA wants this drug approved. If they want it badly enough, there are ways for P3 to be designed that virtually guarantee success, e.g., using a real opioid in the comparator arm with co-primary endpoints of non-inferiority on pain relief and superiority on abuse propensities. I have some other thoughts on viable trial designs with placebo, but there's no point in speculating -- in 4 months or so we'll know what FDA wants. If it's a lay-up SPA, then I strongly suspect they'll cut a Euro rights deal and will be able to fund phase 3 without dilution. If on the other hand it's a phase 3 that leaves open a serious possibility of placebo confounding, then they'll be exposed financially and will have to go it alone, with serious dilution likely necessary unless by some miracle 102 is terminated early on efficacy grounds. But the point is that this could still go a lot of different ways and it really all depends on what FDA wants to see. . . . . . . One way to look at this is that it could have been potentially disastrous if they had narrowly hit the endpoint and then run p3 with the same trial design. At least now they know that there is no placebo rebound with 181 and they can take a shot at getting FDA to buy into a different and potentially viable p3 trial design.

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    • hoyas,

      The simplest explanation for what happened is placebo effect. NKTR has to find some way to refute that hypothesis before NKTR-181 is approved. Hopefully they will do that before spending $100M+ on a Phase III. They ought to run a couple of multi-arm randomized double-blind efficacy studies like are used for NSAID's and COX-2 inhibitors. Pick a type of chronic pain, six weeks, 150 patients in each arm, 200 mg NKTR-181, 400 mg NKTR-181 and placebo. The non-opioids show separation in these types of studies. If NKTR-181 doesn't succeed, then it isn't a very good pain killer. The results from these studies can be part of an NDA package.

      • 1 Reply to dcxavier
      • DCX,
        I think you are leaping to conclusions a bit. While your hypothesis is simple, i am not so sure it is the most logical inference to draw from what we know at this point. Moreover, your hypothesis may also prove to be irrelevant. The proper course at this point is to see what FDA wants and what FDA is willing to take in a p3 trial design. As I said, much depends on how much they want this drug and just how much trial design compromise they are willing to abide to get it.

 
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