Highlights

I think it’s negative symptoms, cognitive symptoms, first rational polypharmacy with different mechanisms of action, but also residual positive symptoms. We don’t have anything but clozapine, which is 50 years old, for treatment resistance, and 30% of patients have a degree of treatment resistance and another 30% have suboptimally controlled positive symptoms. We also need something to improve not just symptoms but functionality and recovery. That’s where we still fail our patients.

Well, having an effective and tolerable bimodal mood stabilizer that is as good to treat acute mania and to treat acute depression and prevent acute mania and prevent acute depression. But short of that, if you have a safe drug that does it either from above or below, patients who are bipolar or who are sensitive to side effects – neuromotor, weight gain, also might not tolerate sexual side effects or weight gain as much because they’re often malfunctional with bad relationships at work.

So, the question then is, who will be eligible for this? I would think it will be patients who are now started on olanzapine, and there are still enough patients who are started, who then demonstrate, in the first two to four to six weeks, weight gain that’s significant. That will also be most likely a requirement by payers. And then it will be hard to deny these patients, who are on the route – early weight gain predicting later weight gain – to gaining a lot of weight, to be switched over to a safer olanzapine. Then it might also be the case that patients who are started on the inpatient unit who are then switched earlier, on the outpatient basis because of dramatic weight gain, when they’re switched to ALKS 3831 might be able to stay on olanzapine in its new form for longer and there is less switching off, and that might be another group after the switch in the outpatient basis that could be maintained.